Validation Technician Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the validation technician job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

F Lubowitz

Francisco

Lubowitz

63977 Hand Drive

New York

+1 (555) 441 0071

63977 Hand Drive

New York

Phone

p +1 (555) 441 0071

Experience Experience

Philadelphia, PA

Validation Technician

Philadelphia, PA

Schultz and Sons

Philadelphia, PA

Validation Technician

Utilizing work instructions and instrument’s specifications, perform various assembly operations
Works directly with management and contract engineers
Assists in performing various validation execution activities
Assist with the execution of Installation, Operational and Performance qualification
 Assists with and performs QMS, GSK internal policy, Global Standard Operating Procedures (GSOPs), CAP and Quality Alert gap analysis
Assists in providing supporting documentation for validation protocols such as lab reports, calibration certificates, etc
Participate and lead improvement events (such as Kaizen, 5S, Practical Process Improvement)

Houston, TX

Laboratory Validation Technician

Houston, TX

Ondricka, Huel and Vandervort

Houston, TX

Laboratory Validation Technician

Laboratory equipment preparation and testing to support Process Development, New Product Introductions and Manufacturing
Preparation of CAD files, 3D-Printing build files and operation of equipment for prototyping and Process development purposes
Co-ordinate laboratory equipment activity to satisfy demands
Develop and implement best practices for laboratory activities. Creation and maintenance of Standard Operating Procedures, maintenance procedures and Health and Safety procedures
Support 3D-Printing prototyping. CAD file preparation, conversion to STL, 3D-printer preparation and operation, post-processing and inspection
Work closely with the Quality Department to ensure all documentation associated with validation and new product introduction in a regulated environment is accurate, executed in the correct sequence and completed in a timely manner
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches

present

San Francisco, CA

Label Software Validation Technician

San Francisco, CA

Lubowitz, Friesen and Breitenberg

present

San Francisco, CA

Label Software Validation Technician

present

Drafts and executes equipment and software DOE’s, installation, operational, and performance qualification protocols, (IQ, OQ, PQ)
Works within FDA and International Standards Organization, (ISO) regulations and the Arthrex Quality Management System
Advises end users on best practices, processes, and system improvements for label printing/scanning operations and related content management
Supports validation activity in the development of Labeling Centers of Excellence globally at manufacturing and distribution sites
Performs first article inspection of new or revised label content
Performs and documents risk assessments and pFMEAs
Participates in CAPA investigations and resolution

Education Education

Associate’s Degree in Engineering

Cornell University

Associate’s Degree in Engineering

Skills Skills

Excellent written and verbal communication skills
Good communication, writing and computer skills
Excellent computer skills, Microsoft Word and Excel
Good organizational skills
Excellent communication skills. Communicates and works with peers in a positive, cooperative way, maintain productive relationships with key functional areas
Demonstrated ability to read, write, and speak clear English
Computer proficiency (i.e. word processing, spreadsheets, presentations, outlook)
Possess and demonstrate excellent verbal, written, and interpersonal communications skills
High level of attention to detail
Excellent documentation skills

Create a Resume in Minutes

15 Validation Technician resume templates

Read our complete resume writing guides

Laboratory Validation Technician Resume Examples & Samples

Laboratory equipment preparation and testing to support Process Development, New Product Introductions and Manufacturing
Co-ordinate laboratory equipment activity to satisfy demands
Perform all necessary laboratory and Product Development testing and supply data required for FDA submissions. Equipment will include metallographic, optical microscopy, chemical and physical analysis, dimensional measurement, First Article Inspection etc. of metals, polymers etc. as required
Conduct DOEs, capability studies, MSAs, Technical report writing, Technical support e.g. workmanship standards, product quality issue resolution, quality control support, engineering support e.g. ECN generation
Support 3D-Printing prototyping. CAD file preparation, conversion to STL, 3D-printer preparation and operation, post-processing and inspection
Provide training for manufacturing team members

Quality Validation Technician Resume Examples & Samples

Drive and/or participate on project teams that require verbal and written communication skills
Plan and schedule work within project schedules and budgets
Identify and recommend improvements in processes on continuing basis and assist in implementation
Review functional and design specifications to ensure full understanding of individual deliverables
Hold and facilitate test plan reviews with cross-functional team members. Identify any potential quality issues per defined process and escalate potential quality issues immediately to management
Ensure that validated deliverables meet functional and design specifications and requirements. Isolate, replicate, and report defects and verify defect fixes
Experiences in JJVC Quality Management Software and Processes (One Voice Complaint Handling System , VIBES Non-Conformance, VIBES CAPA, VIBES Change Control)
Knowledge and experience in technical aspects of software solution being tested
A minimum of a High School diploma with 5 years of large enterprise or e-business systems experience or 3+ years large enterprise or e-business systems experience with a Bachelor’s is required
A minimum of 4+ years of relevant QA technical experience is also required
Expertise in testing in Server environments including designing and manipulating test data is required
The ability to read/interpret/understand written policies, procedures, and instructions is required. Computer knowledge in Microsoft Office applications is required. Advanced experience in SharePoint, Microsoft Excel, and Access is highly preferred
Strong data analysis skills are required
Careful attention to detail and accuracy of work is essential. This position requires an individual who can multi-task, adapt to changes in daily workload and priorities, and function in a cross-functional team setting. Ability to be self-directed and/or work in a team-based environment with minimal supervision is required. The ability to effectively communicate and present information and instruction to peers and/or management representatives within a group or individual setting is required
This position will be based in Jacksonville, FL and will require up to 10% domestic travel

Validation Technician Resume Examples & Samples

Requires ability to communicate effectively verbally and in written form
Knowledge of Universal Precautions, general laboratory and quality assurance/control preferred
Valid driver’s license and good driving record if required to travel to other locations
GED or higher education
Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries
Prefer basic knowledge of refrigerator and freezer operation and temperature distribution patterns in such storage spaces

Validation Technician Resume Examples & Samples

Perform Protocol Executions generated by a senior level Validation Specialist
Write Final Reports
Assist in the review and update of System and Equipment related SOPs
Facilitate the routing and approval of protocols and SOPs
Document deviations, system failures, investigations, and corrective actions
Personal development in the generation of system, equipment and process related validation protocols (IQ, OQ and PQ)
Perform operational monitoring of all facility systems and equipment as part of Engineering Department Requirements
2 years of experience in a regulated environment preferred
Excellent computer skills, Microsoft Word and Excel

Validation Technician Resume Examples & Samples

Assist with the execution of Installation, Operational and Performance qualification
A two year Associates degree in the life sciences or related field is preferred, while a BA or BS degree is a plus
Require a minimum of 1 – 2 years' work experience in the biopharmaceutical industry
Knowledge of basic validation principles, standard concepts, practices, procedures and requirements in a GMP regulated environment is essential
Prefer experience and knowledge in manufacturing processes, laboratory operations and calibration/maintenance activities
Must be comfortable with working in gowned clean room conditions in a sterile environment and perform repetitive tasks
Should be able to transport heavy test equipment across the campus as needed
Must be able to receive general instructions on routine validation work and on new assignments/projects and meet timelines and objectives

Validation Technician Resume Examples & Samples

Listen for Instructions, take notes, ask questions and explain procedures to confirm requirements are understood before starting any testing
Testing of electronic modules during development (ED), DV (Design Validation) and PV (Production Validation)
Testing includes: working directly with a Validation Engineer (VE) to review, understand and execute test instructions. Part sample management, test setups, environmental chamber operation, sample analysis prep, logging, data acquisition and reporting
Work with electronic module test stands to ensure correct setups and execution of active testing on modules
Program, operate, clean, diagnose and provide preventative maintenance of environmental chambers. Understanding of environmental chamber capabilities to make testing and chamber selection decisions
Propose opportunities for preventive maintenance programs, repairs, spare parts, upgrades, or replacement of assets
Perform diagnostics, repair and maintenance of electronic test stands as well as harness build, debug and repair
Work with other department associates to ensure full proxy/backup of all key responsibilities
Support problem solving and continuous improvement (CIP) initiatives to improve efficiency and effectiveness of methods and processes
5S workplace organization awareness and practices
Hands on, be able to perform testing, create/move setups and start/monitor tests
In case necessary deliver parts to external labs and support testing at lab remote locations
Support parts storage practices, labeling and Fixtures organization
Document every test with pictures of setup and follow up chamber working properly by monitoring chamber temps
Keep Testers Schedule and chamber schedules updated upon requests
Soldering, Thru hole components, SMT
Demonstrated ability to conceptualize, coordinate, and integrate internal data and clearly articulate concepts, ideas, and other issues relating to test setups, hardware, and software usage
Must be able to operate standard and specialized equipment related to the job, needs to have experience using test equipment, DMM, Oscilloscope, Video Scope. Ability to calculate and analyze data, generate reports, present information, etc
Excellent communication skills. Communicates and works with peers in a positive, cooperative way, maintain productive relationships with key functional areas
Minimum 1-2 years of college education in an engineering curriculum or demonstrated experience on items above
Prefer Technical/Professional curriculum related to mechanical/electrical/electronic engineering
Technical Understanding of environmental level testing, like temperature, vibration, humidity, enclosure, and associated electrical type tests
Computer proficiency (i.e. word processing, spreadsheets, presentations, outlook)
Demonstrated troubleshooting skills where problems are often difficult and complex

Equipment Validation Technician Resume Examples & Samples

Equipment Qualification and Validation per FDA regulations and guidance, provide technical/scientific, administrative, and logistical support to provide qualification and validation services for laboratory equipment/systems in support of non-clinical and clinical studies; and product development efforts
The Contractor shall provide validation services per FDA regulations, guidance and expectations for studies conducted using Good Laboratory Practices (GLP) CFR 21 Part 58 and Part 11 quality system requirements and expectations. The validation effort shall not exceed FDA expectations for nonclinical validation of equipment and associated software for intended use
Personnel provided by the Contractor shall have education, training and experience necessary to meet FDA regulatory expectations for GLP validation efforts including GLP Training; initial and refresher as appropriate, curricula vita, job description and training assigned by USAMRIID
Validation activities include but are not limited to
Requesting validation and change control numbers from the Document Control Office(DCO)
Generating protocols and change control documents with input from equipment users
Providing quality control review during the execution of the test cases in real time
Preparing the validation and change control documents and records for final approval
Ensuring appropriate validation record archival
Validation schedules shall be updated to reflect current status and all reporting of validation metrics
The Contractor will shall also provide the appropriate staff to attend regularly scheduled Validation and Focus Group meetings as needed
BS or MS degree in biomedical sciences
A minimum of 3-5 years equipment validation experience
Experience in GLP validation

Validation Technician Resume Examples & Samples

The Contractor shall provide validation services per FDA regulations, guidance and expectations for studies conducted using Good Laboratory Practices (GLP) CFR 21 Part 58 and Part 11 quality system requirements and expectations.The validation effort shall not exceed FDA expectations for nonclinical validation of equipment and associated software for intended use
Personnel provided by the Contractor shall have education, training and experience necessary to meet FDA regulatory expectations for GLP validation efforts including GLP Training; initial and refresher as appropriate, curricula vita, job description and training assigned by USAMRIID
Validation activities include but are not limited to
Requesting validation and change control numbers from the Document Control Office (DCO)
Generating protocols and change control documents with input from equipment users
Providing quality control review during the execution of the test cases in real time
Preparing the validation and change control documents and records for final approval
Ensuring appropriate validation record archival
Validation schedules shall be updated to reflect current status and all reporting of validation metrics
The Contractor will shall also provide the appropriate staff to attend regularly scheduled Validation and Focus Group meetings as needed

Validation Technician Resume Examples & Samples

Perform electrical testing of components, printed circuits, assemblies, and systems
Document test plans, test procedures, and test results of each assigned job
Work with Engineering and Assembly, ensuring manufacturing, construction, installation and operations conform to functional specifications and customer requirements

Validation Technician Resume Examples & Samples

Process Validation of MS Word Time/Date Stamp and Lock Functions Produce a Secure, Tamper Free Document in the Windows 7 Operating System for Laptops to provide Emergency Backup of USAMRIID SOPs Process IOPQ
Installation and Operation Qualification for Ortho Clinical Diagnostics VITROS 350
3 (three) analyzers IOPQ
Data Sciences International (DSI) Implantable Telemetry System Using Ponemah Physiology Platform 5.1 with Open ART Platinum Software – Complex System IOPQ
FDA 21 CFR Part 11 Assessment and Remediation Recommendation, if needed, of the Biodefense Laboratory Management System (BLMS) Part 11 Assessment
BLMS Audit Report Routing Sheet Workflow & Electronic Signatures Workflow Process IOPQ
MEDWEB Picture Archiving & Communication System for Use to Support GLP Studies at USAMRIID IOPQ
Software Process Validation of the FileMaker Cell Culture Ordering Application Process IOPQ
Software Process Validation of the FileMaker Cell Culture Liquid Nitrogen Inventory Application Process IOPQ
LabDAQ Laboratory Information System Software IOPQ
EInfotree Microsoft® Excel® Module IOPQ
Validation of Emergency Backup Laptop Solution for USAMRIID SOPs IOPQ
Emka Plethysmography System
4 (four) Systems. Customized System Developed In-House IOPQ
Automated Bioaerosol Exposure System II (ABES II)
10 (ten) Systems. Customized System Developed In-House IOPQ
Retrospective Bioplex FlexMAP 3D Platform IOQ
SECTOR Imager 2400 IOQ
Part 11 Assessment and remediation recommendation, if needed, of the Tecan Infinite M200 PRO Part 11 Assessment
ElproECOLOG-NET LAN IOQ
ElproLOG ANALYZE QLS, USER, MONITOR and EVENT Software Applications IOPQ
Agilent 1290 Infinity II HPLC System
2 (two) Systems IOQ
Advia 120 Hematology System
3 (three) Analyzers IOQ
NC-3000 Advanced Cell Analyzer IOQ
Biotek 405LSU Plate Washer IOQ
Agilent 6150B Mass Spectrometer
2 (two) Systems IOPQ
Siemens Sysmex CA-560 IOQ
The IDEXX VetLab Station IOQ
Piccolo Point of Care Chemistry Analyzer
4 (four) Analyzers IOQ
QARCO Compliance Oversight-FileMaker Pro Database Process IOPQ
Agilent 8453 UV-visible Spectrophotometer IOQ
USAMRIID Building Automation System IOPQ

E-powertrain Validation Technician Resume Examples & Samples

Organizing and maintaining the equipment and laboratory (5S)
Use safety equipment properly and proper use of special tools
Interprets internal and customer specifications for validation test
Setup instrumentation and motor dynamometer testing
Set-up and perform validation test using environmental chamber and chiller
Gather and analyze the data, and provide the report
Calibrate and verify the measuring equipment
Review established company safety checklists or work instructions to ensure machines are operating safely and are properly maintained
Utilize hand tools and visual inspection to analyze root cause
Complete weekly status reports and identify and communicate roadblocks to team

Validation Technician Resume Examples & Samples

Validates new and existing equipment, utilities, and processes by executing pre-approved validation protocols. May also modify existing validation protocols or create new ones
Installs new equipment by establishing, adjusting, calibrating, and testing performance. Coordinates calibration activities with external vendors as required
Maintains equipment by completing preventive maintenance schedules; conducting tests; following manufacturer's instructions; troubleshooting and repairing malfunctions; calling for special service; evaluating service contracts; maintaining equipment inventories, and ensures complete equipment files
Improves equipment performance by studying machine operation; conferring with equipment users; developing modifications; collaborating with equipment manufacturers
Prepares reports by collecting, analyzing and summarizing information and trends
Maintains safe and healthy working environment by conducting safety tests; recommending and complying with procedures; training and guiding personnel; complying with codes related to a medical device manufacturing environment (e.g. ISO 13485)
Updates job knowledge by participating in educational opportunities; reading technical publications; maintaining personal networks
College diploma in a relevant discipline and/or an equivalent combination of education and technical experience acceptable to Epocal
Strong documentation skills preferred
Experience in a lab environment is preferred
Experience with equipment calibration and light maintenance is an asset

Validation Technician Resume Examples & Samples

Utilizing work instructions and instrument’s specifications, perform various assembly operations
Active member of production cell. Participate and support inventory and equipment management as related to the cells operations requirements
Cross train into other functional roles as required
Participate in daily team stand-up meetings; communicating daily challenges and/or ideas
Participate and lead improvement events (such as Kaizen, 5S, Practical Process Improvement)
May be required to rework or reassemble units based on verbal or written instructions for failure analysis or development activities. Assignments may be complex and non-repetitive. Some personal judgment may be needed
Make changes to written processes and procedures
Perform transactions in MRP system
Maintain a safe working environment, following established 5S procedures
Conduct Morning Cycle Count and assist with reconciliation of inventory
High School diploma or equivalent. 5+ years of related experience, preferably in a manufacturing environment
Good math and computer skills. Ability to perform basic operations in Microsoft Word and Excel
High visual acuity and manual dexterity. Ability to conduct equipment set up and qualification on simple machinery as well as experience doing in-process visual inspection
Ability to read, analyze, and interpret technical procedures and drawings and interpret component orientation
Familiarity with Lean Manufacturing concepts a plus
Soldering experience a plus

Validation Technician Resume Examples & Samples

2 – 3 years in Pharmaceutical Industry
 Responsible for ensuring all aspects of the Validation Lifecycle are in place (leads validation working party) and actively maintained for the systems comprising equipment (including control and analytical systems), facilities, utilities, and IT systems or cleaning processes: Prerequisites for Validation, Planning and Requirements, Verification of Design, Testing and Qualification, Summary Reporting, Maintaining the Validated Status, Decommissioning of Validated Systems. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
 Prepares and executes Validation Master Plans, Validation Plans and Protocols for the validation of systems and processes as per latest industry and GSK policies, procedures and guidelines and as advised by Validation Lead. Compiles validation reports documenting the outcome of the validation study (and translation to standard work as per the principles of GPS)
 Ensures system and process validation status is maintained by performing, coordinating or having input into periodic system, cleaning process and product reviews (as directed by the Validation Lead). Ensures re-validation of systems and cleaning processes as required
 Responsible for assessing change control requests, unplanned maintenance activities, non conformances and CAPAs for the impact of change on validation status, assists in developing appropriate change management / CAPA action plans (including revalidation requirements) and supports approved change plans with respect to validation activities
 Troubleshoots problems that occur with validated systems and manufacturing cleaning processes and provides technical participation in Root Cause Analysis (RCA) investigations as required
Provides technical input to annual reports, Periodic Product Reviews and internal and external audits
 Conducts self inspections and supports internal and regulatory audits
 Provides technical expertise with respect to systems or cleaning processes in support of Product Life Cycle Management / Process Robustness and other GSK or site initiatives
 Coaches others in his/her area of expertise, ensuring other functions (e.g. Operations, Engineering, Technical) have sufficient system / cleaning process knowledge and understanding to execute their roles
 Assists with and performs QMS, GSK internal policy, Global Standard Operating Procedures (GSOPs), CAP and Quality Alert gap analysis
 Updates Validation standard operating procedures and conducts staff validation training as required
6 Co-ordinates the system risk assessment
7 Assists with supplier assessments
8 Reviews Factory Acceptance Testing (FAT) Protocol, attends and executes FAT with supplier if required
9 Develops the test protocols / scripts and records
10 Performs or, oversees the performance of, the required monitoring/tests after commissioning
11 Ensures calibration of critical and diagnostic instrumentation and addition to the routine calibration program is identified during qualification
12 Provides input into and ensures preparation (or revision) of applicable system standard operating procedures (SOPs)
13 Liaises with projects, supply planning, departmental personnel and contractors/suppliers as required
14 Takes appropriate corrective/remedial or preventive action for non-conformances/failures
15 Collates and reviews data
16 Prepares the Validation Report(s)
17 Trains personnel with respect to validation requirements and assists with training with respect to system operation and maintenance
18 Facilitates and performs periodic reviews of validated systems. Ensures maintenance of the validated status or initiates appropriate corrective action
19 Revalidates systems as per the revalidation program or, as required
20 Evaluates change control requests, non conformances and CAPAs for the impact of change on validation status, assists in developing appropriate change management / CAPA action plans and supports approved change plans with respect to validation activities
3 Facilitates and participates in Technical Risk Assessments (TRA) as per site agreed schedule
4 Provides input into equipment qualification working parties in regard to cleaning validation lifecycle requirements
5 Co-ordinates cleaning procedure risk assessments
6 Prepares the Validation Master Plans, Validation Plans/Protocols
7 Develops, executes and records the sampling and test plans
8 Carries out or, oversees the performance of, the required monitoring / test plans
9 Investigates processing/procedural problems and/or failures and applies effective remedial action (in consultation with Validation, Technical, Production and QA Management)
10 Coordinates the various validation activities with production and QA personnel
11 Arranges for the analysis of samples
12 Collates, summarises and reviews the data
13 Ensures preparation (or revision) of applicable system SOPs, standard work and Master Documents
14 Prepares the Validation Report(s)
15 Trains personnel (or assists with the training) with respect to validation requirements and outcomes
16 Assures that ongoing monitoring (Continued Process Verification) is in place
17 Performs cleaning periodic reviews of validated systems. Ensures maintenance of the validated status or initiates appropriate corrective action
18 Revalidates cleaning processes as per the revalidation program or, as required
19 Evaluates change control requests for the impact of change on validation status (including updates to product and equipment cleaning matrices as required), assists in developing appropriate change management action plans and supports approved change plans with respect to validation activities
COMPLIANCE
5 Attend monthly Value Stream Quality Councils (VSQC) as required
EHS
2 Assists with the delivery and achieving the GMS goal of Zero Accidents, Zero Defect and Zero Waste goal on site
3 Participates in “visual factory”, incorporating 5S

Validation Technician Resume Examples & Samples

Responsible for assessing change control requests, unplanned maintenance activities, non conformances and CAPAs for the impact of change on validation status, assists in developing appropriate change management / CAPA action plans (including revalidation requirements) and supports approved change plans with respect to validation activities
Conducts self inspections and supports internal and regulatory audits
21 Computerised Systems
1 Ensure compliance with internal and external computerised system policies and regulations
Perform gap analysis against GMS and global ITMS system validation policies and GSOPs
Liaise with CSQMS, AEQMS and ITMS system validation specialists across the GSK network in order to share good practice methods and tools
2 Organise site for computerised system validation activities
Ensure all centrally produced tools, templates and materials are available and relevant to site and are specified in local operating procedures
Maintains the computerised system register
3 Provide and deliver training/mentoring for computerised system validation to all relevant site personnel. Co-ordinate computerised system validation activities
Ensuring key personnel, training and experience is in place before beginning any computerised system validation activities
Provide GxP and regulatory input into computerised system implementation projects with particular focus on impact to patient safety, product quality and record integrity
4 Monitor/support on-going computer compliance
Perform periodic system reviews ensuring that the systems maintain their validated status
Provide CSV related responses to inspectors/auditors
Develop and maintain links with above-site and regional site validation teams both to learn from and contribute to GSK’s validation practices
210 Coordinates the various validation activities with production and QA personnel
1 Complies with EHS standards and guidelines and Site EHS SOPs
2 Provides input into EHS risk assessments for new and existing systems and processes
3 Attend weekly stop for safety sessions
GSK PRODUCTION SYSTEM

Validation Technician Resume Examples & Samples

Participates in team effort by performing according to the guidelines outlined in STERIS Code of Business Conduct, the GMP and other directives; supporting the directives and decisions of higher level management and accomplishing other duties as assigned
Follow established processes and SOPs to completed daily tasks
Exhibits a commitment to assisting others to meet the Customer's needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer's needs with a sense of urgency

Validation Technician Resume Examples & Samples

Contributes to the accurate and safe processing capability of the company by coordinating and scheduling all Customer validations and dose mappings; calibrates and maintains proper function of data collection devices used in validations and qualifications; investigates analyzing and reporting procedures and provides solutions to process deviations and Customer complaints
Optimizes processing by coordinating scheduling of Customer product; assists plant management in training operations employees in performing process procedures; assists operations as required to ensure the timely movement of product. May provide guidance and supervision to Irradiator Operators and Material Handlers
Provides Customer service by assisting in the performance and adherence to ISO 11135 and ISO 11137 requirements
Strives for continuous improvement by analyzing new or alternative ways to improve operations; incorporates staff recommendations into analysis; responds to audit activities in a constructive manner and uses findings to improve operations where possible
Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, and other directives; supports the directives and decisions of higher level management and accomplishes other duties as assigned
Provides employee protection by promoting and issuing monitoring devices in hazard areas as required by safety rules and laws
Supports the STERIS AST business imperatives of Growth, Operational Excellence, Leadership Excellence and Customer Focus, by acting with integrity, treating everyone with mutual respect, exhibiting a genuine commitment to the success of all employees, and delivering satisfaction to our Customers through teamwork,
Ability to effectively write and verbally communicate in English
Ability to work independently under general guidelines and supervision
Effective interpersonal skills as demonstrated through prior management experience
Requires ability to navigate through defined computer screens
Above average organizing and analyzing skills and Level 2 math skills (four basic arithmetic functions in all

Test & Validation Technician Adas Resume Examples & Samples

Set up ADAS electronics lab and Garage
Modify electrical prototypes, parts, assemblies, or systems to correct functional deviations
Provide complete and accurate documentation of new installations and/or modifications to existing equipment
Build, calibrate, maintain, troubleshoot, and repair electrical instruments or testing equipment
Set up and operate test equipment to evaluate performance of developmental parts, assemblies, or systems under simulated operating conditions, and record results
Place and track orders for parts/services
Keep proper stock of components
Keep proper stock of garage material

Validation Technician Resume Examples & Samples

Execute validation protocols
Review protocols
Create, maintain, inventory, safeguard and update validation records
Coordinate validation activities and work closely with, but not limited to, Microbiology, Chemistry, Maintenance, and Manufacturing departments
Operate data logging system(s) (Ellab TrackSense) for qualifications of steam processes (sterilizers and Steam-In-Place (SIP)) and temperature controlled units (stability chambers, incubators, refrigerators, freezers, ovens)
Review and analyze validation data and write summary reports
Regular re-evaluation and continual optimization of protocols, qualifications and validation activities
Planning, design, and implementation of validation projects, protocols, and SOPs
Purchase supplies and equipment for validation activities

Validation Technician Resume Examples & Samples

Assists in performing various validation execution activities
Prepares and executes simple validation protocols under the supervision of a Validation Engineer
Routes and tracks protocols and other documents for approvals
Maintains validation documentation and oversees the Validation vault
Assists in audit activities by providing the relevant validation documentation when needed
Maintains and reports validation metrics
Scans protocols into the Validation SharePoint site
Assists in scheduling and coordination of validation activities
Assists in providing supporting documentation for validation protocols such as lab reports, calibration certificates, etc
Assists in maintaining and supporting Protocol Log software
Assists the Validation department in developing policies, programs, SOPs, and Quality Standards to meet current industry, corporate Quality, and external Regulatory requirements
Assists with setup and maintenance of Validation equipment
Works directly with management and contract engineers
Maintains effectiveness of the Quality System components relevant to this position
A minimum of two years of experience in pharmaceutical manufacturing and operations
Knowledge of cGMPs, pharmaceutical manufacturing methods and general validation principles
Knowledge of and adherence to Catalent Good Documentation Practices
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Learn new skills; collect new information. Demonstrate a willingness to share skills and information with others
Demonstrate initiative. Develop ideas, and collect them from others. Continuously seek opportunity. Clarify issues, investigate
Full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred
Demonstrate sound time management practices in order to priorize workload and meet project deadlines
Possess and demonstrate excellent verbal, written, and interpersonal communications skills
Demonstrated ability to read, write, and speak clear English

Label Software Validation Technician Resume Examples & Samples

Participates in planning for hardware and software related to labeling operations, including, barcode scanners, label design software, vision inspection systems, barcode verifiers, and label printers
Drafts and executes equipment and software DOE’s, installation, operational, and performance qualification protocols, (IQ, OQ, PQ)
Participates in value stream mapping activities related to labeling operations, including, label printing, barcode scanning, and barcode inspection
Participates in process user acceptance testing (UAT) and documents defects
Records and documents validation and qualification data accurately per written protocols and data collection forms
Investigates and resolves non-conformances related to labeling production systems and associated hardware and software functionality
Participates in CAPA investigations and resolution
Performs and documents risk assessments and pFMEAs
Maintains validation traceability records and equipment matrices
Performs first article inspection of new or revised label content
Supports Supplier Quality in establishing requirements for outside supplier label printing approvals
Supports validation activity in the development of Labeling Centers of Excellence globally at manufacturing and distribution sites
Advises end users on best practices, processes, and system improvements for label printing/scanning operations and related content management
Works within FDA and International Standards Organization, (ISO) regulations and the Arthrex Quality Management System
High school diploma or equivalent required
Associates Degree or some college experience is preferred
Experience with thermal transfer printing and barcode scanning equipment is preferred
Experience with enterprise labeling software and relational databases is preferred
Experience working in an FDA regulated industry is a plus
ASQ training or certification a plus
Strong organizational skills and the ability to manage multiple tasks on tight timelines
Strong customer focus and responsiveness
Proficiency in basic Windows applications required (Word, Excel, Outlook, and PowerPoint)
Experience with HP ALM is a plus
Previous experience with process design and lean implementation is a plus
Ability to adapt to new technologies and a rapidly changing environment

Validation Technician Resume Examples & Samples

Organize and maintain laboratory and all equipment. (5S)
Review established company safety checklists, and/or work instructions, ensuring all equipment is functioning in a safe efficient manner, and are properly maintained
Adhere to safety policies at all times. Use tools and equipment in a safe and effective manner
Utilize appropriate ppe (personal protection equipment) when necessary
Interprets external and internal work instructions, to perform test to required specification
Set up, install, and monitor motor on motor dynamometer
Set up, install, and monitor components being tested using environmental chamber and chiller
Gather and analyze test data. Provide written report
Calibrate tools and equipment as necessary, maintain records of calibration
Utilize hand tools and visual inspections to perform Root Cause Analysis on faulty components
Evaluate and escalate complex concerns to the appropriate leadership and management for input and resolution
Identify any complications or concerns while performing job duties, effectively communicate these concerns with rest of team for assistance and possible resolution
Create weekly status reports for supervisor
LI-SB1

Validation Technician Resume Examples & Samples

Development and execution of routine validation documents and final summary reports for equipment and/or processes
Development of periodic reviews for equipment and/or processes
Scanning, sorting and filing of validation documents
Handle multiple projects and work independently
Operate typical office equipment such as computer, document scanners and copiers
Develop, execute and summarize validation protocols
Work independently
Must understand instructions and react favorably in complex situations
Must be mentally flexible in dealing with difficult situations
Good communication, writing and computer skills
Associates degree in engineering or life sciences degree is preferred, but not required. High School Degree at a minimum or equivalent
Experience in a manufacturing or laboratory environment is a plus

Motor Validation Technician Resume Examples & Samples

Manage the day-to-day operations of the measurement lab, including administrative work
Support the team to measure the parts, assemblies
Support the team with the build activities
Responsible for parts inspection report
Set up and drive quality improvement initiatives and actively track the performance against set deliverables
Closely work with the team to execute measurement and build plan
Setup test rigs and equipment in accordance to the test requirements
Perform validation and investigative testing in accordance to the respective standards or Dyson Test Method and report the results
Diploma or Degree in Mechanical/Electronics/Mechatronics Engineering
Minimum 3 years’ work experience in Quality / Process capacity in a manufacturing industry
Knowledge in the field of Quality Assurance and its application
Able to understand and apply various quality tool and techniques such as Fishbone, Pareto, Cause-and-Effect
Knowledge of basic statistical principles and its application is a must
Knowledge and practical experience in measurement equipment (CMM, Roundness, Vision measurement) would be an added advantage
Able to understand part drawings, including GD&T requirements

Software Validation Technician Resume Examples & Samples

Creating Design Verification Plan and Reports (DVP&R) for engine, pc based engine diagnostic tool, helm and MFD software
Testing software functionality on bench systems and documenting results, working with Software Engineers in an iterative fashion until testing and verification is complete
Boat and test bench rigging and fixturing. Test harness prototyping

SSD Validation Technician Resume Examples & Samples

Build and configure system test hardware and software in a complex automation environment
Build and Configure next generation pre-production platforms and test with SSDs
Execute validation test suites on Solid State Drive configurations at the system level
Isolate failures at the system level and interpret those failures and provide a summary to the Execution Lead Drive improvements into existing validation test suites and methodologies
Providing training or assistance to other technicians
4 years industry experience as a validation or engineering technician, including setting up and maintaining validation systems and infrastructure
Extensive hands on experience building and configuring PCs from components and troubleshooting issues
Experience executing system level test plans and reproducing test failures
Experience supporting unit and system level product testing in a fast paced, dynamic lab environment
Experience with Windows and Linux operating systems
Self-driven individual who is capable and excited to learn about new technologies
Scripting and high-level software language skills, such as C++ & Python is a plus- Knowledge of SATA and PCIe interface RAID knowledge is a plus

Test Validation Technician Resume Examples & Samples

Set up DV and PV testing together with the Application Engineers
If needed, order necessary tooling to run the test
Schedule testing according to customer timing
Operate the testing in our lab or organize an external Lab
Prepare the test reports
Support the team for D-FMEA and P-FMEA
Ordering the needed parts and tooling for the tests
Communicate test result with the customer
Support the sales team for project related tasks
Min. 2 years engineering experience in the automotive industries within testing/ Lab environment
Familiar with automotive specs and drawings
Technician
Bachelor’s Degree in Mechanical Engineering
Knowledge of GM / Ford Web based data ( COVISINT )
Basic experience in SAP
Experienced with MS Office tools

Validation Technician Resume Examples & Samples

Be an experienced Electronics Technician with a good understanding of lab equipment (scope, function generator, counter, power supply ...)
Have experience with lab equipment control (e.g. GPIB)
Have basic knowledge of a programming language (e.g. C, Python, TCL ...)
Have basic knowledge of statistics (e.g. sample size, standard deviation ...)
Have solid computer & typing skills and be able to write test reports using Microsoft Windows, Word, & Excel
Diploma from a technical college (e.g. Algonquin) OR Bachelors Degree
Two or more years of related electronics experience

Repair, Test & Validation Technician Resume Examples & Samples

Electronic Testing on analogue and digital circuitry
Calibrating and servicing a range of boards, products and systems
Fault finding to component level on complex equipment and systems involving analogue and digital electronics
Repair faulty PCB’s, make up prototype PCB’s
Preparation of test documentation: Test specifications and procedures
Provide hands on support in the full life cycle of products, documentation, servicing and repairs
Liaising with internal departments on test procedures/results
To dress and act in a professional manner at all times as per Company Policy
To comply with safe working practices in accordance with Company safety policies
To perform any other duties as may be reasonably required commensurate with grade and experience
Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math) or equivalent knowledge and experience
Has the ability to break down problems and estimate time for development tasks
Understands the technology landscape, up to date on current technology trends and new technology, brings new ideas to the team
Displays understanding of the project’s value proposition for the customer. Shows commitment to deliver the best value proposition for the targeted customer
Learns organization vision statement and decision making framework. Able to understand how team and personal goals/objectives contribute to the organization vision
Voices opinions and presents clear rationale. Uses data or factual evidence to influence
Completes assigned tasks on time and with high quality. Takes independent responsibility for assigned deliverables

Mems Validation Technician Resume Examples & Samples

Help Validation Engineers with test setups. Soldering components and modifying engineering boards
Setup and execute automated tests in the lab using automated scripting environment
Debug test setup issues and debug/develop test scripts
Maintaining lab equipment and engineering boards
Associate's degree in Electronics Engineering Technology or closely related discipline and 3+ years of experience
Surface Mount (SMT) solder/unsolder/rework Skills
Experience working with lab equipment such as Audio Precision, oscilloscopes, multimeters, power supplies etc
Organizational skills to record, organize, and report validation setups and results in relevant methods
Experience installing/configuring Windows OS and software, driver installation/debug, general OS debug, and working with data in Excel
Basic software knowledge in text-based programming such as C or scripting language such as Python

Validation Technician Facility Management Resume Examples & Samples

Writing, executing and commissioning validation and qualifications protocols that challenge the critical parameters related to installation, operation and performance of the related systems (e.g. HVAC, storage locations & rooms, technical systems and equipment) as per GxP regulations and internal procedures & policies
Preparing and executing periodical tasks such as Re-Assessments, Re-Qualifications, Re-Mappings and reviews as per GxP regulations and internal procedures & policies
Plans and carries out documentation for actions and follow-up on CAPAs together with the FM team on any incidents and none-compliance
Initiating change control, tracking and follow-up on activities (audit observations, CAPAs, none-compliance and incidents) applicable to Facility Management and technical infrastructure
Support FM Department in documentation aspects for specific projects and daily business as necessary
Providing hand’s-on support for daily business to the Facility Management team

Download Validation Technician Resume Sample as Image file