Engineer, Validation Job Description
Engineer, validation
provides technical expertise in measurement equipment (Ultrasonic meters, Coriolis meters, Orifice meters, Gas Chromatograph, fuel meters, H2O Analyzer, H2S Analyzer, O2 Analyzer, CO2 Analyzer and Hydro Carbon Dew point Analyzer) with capital project execution with support on installation, diagnostic, configuration and troubleshooting of said equipment.
Engineer, Validation Duties & Responsibilities
To write an effective engineer, validation job description, begin by listing detailed duties, responsibilities and expectations. We have included engineer, validation job description templates that you can modify and use.
Sample responsibilities for this position include:
Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples
All work includes protocol write-up, sampling plan generation, scheduling, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout
Provide Technical expertise within a wide range of technical projects within the IPT/COE, such as the validation of new equipment, improvement to the filling process
Functional analysis and review of requirements and specification documents
Design test cases and test scenarios based on requirements, user stories or specifications
On customer site, organize and manage all activity and resource related to train qualification, and ensure the interface with the customer
Working knowledge of HIL HW and SW test environment including Plant Models, Harnesses, Load boxes, FIUs, Controllers
Facilitate successful team behavior within Quality Systems and across functional areas
Build cross-functional and cross-departmental support, fostering overall effectiveness
Assessing and processing validation protocols
Engineer, Validation Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Engineer, Validation
List any licenses or certifications required by the position: ISTQB, ASQ, ISO, DFSS, PMP, ISEB, CQE, CCNA, HEPA, CIP
Education for Engineer, Validation
Typically a job would require a certain level of education.
Employers hiring for the engineer, validation job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Computer Science, Education, Electrical Engineering, Chemical Engineering, Mechanical Engineering, Medical, Chemistry
Skills for Engineer, Validation
Desired skills for engineer, validation include:
Testing medical products
Electronics Lab equipment
FDA/cGMPs and global regulatory for Medical Devices
Logic Analyzer
Oscilloscope
Protocol Analyzer
Functional and non-functional software testing
Multiple scripting languages
Quality Concepts
PCIe
Desired experience for engineer, validation includes:
Knowledge of software testing best practices
Working with the in house product teams develop and document the SOW
Minimum requirements include a Bachelor's degree in a technical discipline, preferably engineering or biological sciences and 0-3 years pharmaceutical and/or biopharmaceutical industry experience
Candidates must have demonstrated experience in the delivery and management of Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards
The successful candidate will have at least 5 years experience implementing and supporting automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries
4/5+ years of experience in the medical device and/ or pharmaceutical industry
Engineer, Validation Examples
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Engineer, Validation Job Description
Job Description Example
Our company is searching for experienced candidates for the position of engineer, validation. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for engineer, validation
- Is able to work independently and able to apply validation principles to work assignments, reviews and approves documents and resolves problems
- Certify FBS environmental monitoring/recording devices
- Participate, facilitate and/or support validation training and project management activities as required
- Participates on cross-functional project teams like Operations, Facilities, and Quality Assurance groups
- Serves as an information resource to contractors and vendors
- Assure compliance to cGMP parts 210 and 211 and company quality systems
- Follow standard operating procedures (SOPs), facility safety guidelines, and Food & Drug Administration (FDA) requirements which may include compliance with cGMP CFR parts 210 and 211 where applicable
- Assist with contractor audits, supplier audits, pre-delivery inspections and on-site factory acceptance tests when related to validation
- Uphold safety, quality and housekeeping standards in the lab
- Maintain schedules and timelines, identify possible problem
Qualifications for engineer, validation
- Proficient in current Good Manufacturing Practices (GMPs)
- Full working knowledge of equipment and systems
- Develop DV / PV test plans and reports for all assigned projects and interface with
- Participate in process action teams as part of the global product engineering
- Able to work in a dynamic, fast paced team environment
- Must have validation experience with preference for biologics industry
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Engineer, Validation Job Description
Job Description Example
Our growing company is looking for an engineer, validation. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for engineer, validation
- Lead and/or coordinate investigations into failures to meet acceptance criteria, and determine and implement appropriate resolutions
- Investigate/troubleshoot problems for computerized systems, automated equipment and control systems, establishing and managing appropriate CAPAs
- Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change
- Validate and implement medical device manufacturing processes as assigned
- Identify equipment/fixture installation qualification requirements
- Characterization of processes and their outputs/acceptance criteria
- Written preparation of applicable validation reports that meet regulatory/company standards
- Develop data acquisition suites to support characterization of R&D prototypes
- Develop new measurement analysis techniques and systems for checking device compliance to specification
- Create associated software and hardware for prototype measurements
Qualifications for engineer, validation
- 5-6 years of experience in pharmaceutical or related industry or an equivalent combination
- Excellent organizational skills, capable of multi-tasking and creating validation/qualification
- Requires a BA/BS in Life Sciences, Biology, Microbiology, Biochemistry or Chemistry
- Responsable de validación de componentes de moldes
- Responsable validación electrodos
- Responsable de política de calidad de Tool Room
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Engineer, Validation Job Description
Job Description Example
Our growing company is hiring for an engineer, validation. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for engineer, validation
- Analyse engine test data to identify reliability & durability issues, verify the validity of test conditions, and investigate the root cause of failures
- Work with component teams, test engineers, and the project leads, to drive decision making from engine data reviews and end of test inspections
- Liaise with application leads & customers to plan in field validation opportunities
- System/Platform and SSD level debug
- Interface across the organization to drive improvements into test and debug capabilities
- Expose product deficiencies based on requirements of datacenter storage customers
- Prepares test scripts, collects and organizes test data
- Documents results of tests effectively, to support the efficient resolution of any problems
- Works with IT Infrastructure Services to gather and draft requirements for qualifying infrastructure
- Works with IT Infrastructure Services management to ensure internal procedures for IT Infrastructure Qualification are followed
Qualifications for engineer, validation
- Prefer Qualification experience with IQ/OQ/PQ protocol development/writing/execution
- Must be able to travel to client sites as needed and assigned
- Able to assess/interpret statistical data process capability, control charts, DoE, MSA
- Root cause experience
- Ability to run customer reports
- It would be preferred if you haveknowledge of database servers (SQL Server, Oracle)
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Engineer, Validation Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of engineer, validation. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for engineer, validation
- Authors IQ/OQ/PQ protocols in conjunction with manager/other (and subsequently independently) validation group members
- Tracks validation samples, QC results and authors final reports for validation studies executed
- Confirms SOPs are in place and systems are operational prior to beginning validation studies
- Communicates technical issues to validation engineer II//III and/or manager for resolution
- Responsible for validating, at a minimum, the SIP of vessels, including Bioreactors and varying sizes of fixed vessels
- Assist in the development of system/equipment matrices/bracketing approaches to streamline the validation approach
- Assisting in audit preparation and presentation of the above systems for internal, vendor and regulatory audits
- Liaising with suppliers and conducting Factory Acceptance and Site Acceptance tests where applicable
- Point validation person for review for all associated vendor packages
- Liaise with CQV start-up team in relation to punch list closure both pre-mechanical completion and during the CQV execution phase
Qualifications for engineer, validation
- Bachelor’s degree in Engineering or Engineering Technology (Mechanical, Electrical, Biomedical)
- Knowledgeable on regulatory requirements, FDA 21 CFR 820/GMP Medical Device Regulations
- Experience with different manufacturing processes, such as automated assembly lines, manual assembly processes, molding processes and packaging processes
- Validation experience, process and equipment qualification (IQ,OQ,PQ), Test Methods & GR&R’s
- Process development/characterization experience
- Ability to analyze data through the use of statistical principals
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Engineer, Validation Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of engineer, validation. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for engineer, validation
- Manage and maintain all Refrigerators, Freezers (CTUs) and Walk-In Cold Rooms/ Warehouse Storage Facilities within a proper validated state according to FCS standards
- Lead and further develop the Engineering Validation Department in conjunction with Manager, Validation Engineering
- Plan and formulate aspects of engineering projects such as objective or purpose of project, applications that can be utilized from findings, costs of projects, and equipment and human resource requirements
- Develop, procure, and implement new technologies and innovations either through internal channels and development and/or use of outside technologies and suppliers
- Maintain FCS validation methodology in accordance with applicable Quality/Regulatory requirements and industry best practices
- Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials and facilities
- Perform technical reviews and interpret data for accuracy of equipment/process performance for completed validations/revalidations
- Author SOPs related to validation/re-validation activities
- Represent validation in cross-functional meetings/projects as required
- Ensure and/or execute proper calibration and maintenance of test equipment used for validation/revalidation of equipment and processes
Qualifications for engineer, validation
- Or pharmaceutical environment
- Knowledge of computer software as it pertains to engineering responsibilities
- 2+ years experience in a medical device manufacturing environment
- Applied knowledge of FDA and international medical device regulations
- Demonstrated ability to effectively work cross-functionally with Product Development, Operations and Marketing
- Demonstrated ability to serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention of manufacturing equipment and processes specific to medical device manufacturing