Validation Lead Job Description
Validation lead
provides software SDLC (Software Development Life Cycle) and validation expertise with regulatory compliance guidance and direction in order to meet with GMPs, FDA 21CFR820, FDA 21CFR11, GAMP, IEC 62304, and applicable regulations for computerized systems with the Flex Global IT as well as Flex Health Solutions organizations.
Validation Lead Duties & Responsibilities
To write an effective validation lead job description, begin by listing detailed duties, responsibilities and expectations. We have included validation lead job description templates that you can modify and use.
Sample responsibilities for this position include:
Work on build systems, installers, scripting, unit test systems such as NUnit, JUnit
Leveraging the enterprise and CRM tools and applications to efficiently meet objectives
Provide coaching and guidance to engineers within the project team
Responsible for review and approval of cleaning validation documentation
Establish, write, maintain Validation Master Plan for process, equipment, controlled area and packaging validation, through the team of Validation Experts
Support Site MS&T Head in ensuring that responsible departments
Execute and maintain the VMP activities including revalidation procedures
Maintain overview of state of validation at Site and establish the project prioritization across site
Partner with Quality based on feedback
Partner with Engineering and IT to define the process validation/ equipment/systems qualification interface
Validation Lead Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Validation Lead
List any licenses or certifications required by the position: ISTQB, CM, EMC, PMP, ISEB, PRINCE, RF, ITIL, ASQ, CTFL
Education for Validation Lead
Typically a job would require a certain level of education.
Employers hiring for the validation lead job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Computer Science, Electrical Engineering, Science, Computer Engineering, Technical, Technology, Electronics, Education, Communication
Skills for Validation Lead
Desired skills for validation lead include:
Quality systems and regulatory requirements across multiple health authorities
Applied statistics
GAMP 5
Agile software development
Software testing methodologies
Good Clinical Practices
Python
Logic analyzers
Relevant debug tools protocol analyzers
Scopes
Desired experience for validation lead includes:
Knowledge and experience in Android OS will be a benefit
Knowledge and experience in Computer Vision will be a benefit
Familiar with Microsoft Client Operating Systems, Linux Operating Systems, virtualization software (VMware, Xen, et al), and validation/certification processes for each of these environments
Familiar with system component compatibility and stress testing
Familiar with high performance client IO adapters, drivers, and stress testing
Familiar with power management products and standards
Validation Lead Examples
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Validation Lead Job Description
Job Description Example
Our growing company is looking for a validation lead. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for validation lead
- Ensure CPV plans are in place to monitor and trend critical process parameters, quality attributes
- Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritization of activities against the business needs
- Set local procedures & templates for respective validation documentation and validation master plan
- Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections no critical observations related to validation activities
- Develop, achieve approval for and publish annual Site Validation Schedule
- Develop and maintain Site Inventory List
- The Lead Validation Engineer represents the Validation Department as a leader and contributor during validation projects with site strategic impact
- Develop automated and manual based simulators via LabView and VeriStand
- Create and maintain overall board validation plan
- Experience in validating LabWare LIMS version 6, he will not be doing any configurations
Qualifications for validation lead
- Familiar with general Computer Architecture concepts
- Familiar with Microsoft Server Operating Systems, Linux Operating Systems, virtualization software (VMware, Xen, et al), and validation/certifications processes for each of these environments
- Familiar with MS Office & MS Project tool suites
- Familiar with microprocessor bring-up and debug
- Familiar with C/C++, JAVA, and scripting language programming
- Leading a team of software test engineers/specialists
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Validation Lead Job Description
Job Description Example
Our company is looking for a validation lead. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for validation lead
- Developed thorough test plans to validate accuracy and consistency of electronic data entered in, retrieved via, or routed through LabWare LIMS
- Develop and maintained the Requirements Traceability Matrix to track requirements during the QA Testing Phase
- Execute Scripts for the formal validation process with implementation of GMP
- Good communication skills and leadership quality
- Nice to have – would helpful if he has skills to validate deliverables - FS, DS, the primary responsibility will be testing
- Experience with data migration testing would be a plus
- Coordinate and revise Design Verification and Validation (V&V) Procedures
- Plan the setup and configuration of Test Equipment
- Plan & perform dry runs and formal Verification and Validation (V&V) activities as required
- Oversee the test cycles for V&V activities
Qualifications for validation lead
- Evaluating test resource utilization including equipment utilization
- Developing group metrics to measure test coverage, test process efficiencies and software reliability
- Evaluate existing test cases, creating new test cases and taking other necessary actions conducive to improving software quality and reliability
- Executing test plans and tracking software defects/bugs
- Be responsible for the overall quality of the software
- Refining processes for testing and validation of existing and future software releases to ensure consistent/repeatable verification, reliability and robustness
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Validation Lead Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of validation lead. 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 validation lead
- Oversee the execution of approved test scripts to validate Test Results conforms with Design, FRS, URS, SOPs, Traceability Matrix in compliance with cGMP and GDP requirements
- Defines or helps define testing strategies for the overall department for projects and systems
- Functional Mobile Tester
- App Testing (iOS and Android)
- Life Science Validation Knowledge (21CFR Part 11, 820, GxP)
- Expertise in Test Management, Design verification Strategy and Planning, test execution, Regression test strategy, Design verification summary report , defect report documentation.
- Review executed copies of System Integration test scripts & support User Acceptance Test
- Strong emphasis on electrical systems test
- Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols
- IQ,OQ,PQ), Incident Report, RTM and Validation Summary Report
Qualifications for validation lead
- Creating and revising software release instructions, software update instructions, test reports and related technical documentation
- Take steps necessary to ensure that final product meets defined requirements
- Must possess hands-on experience in Trackwise
- Knowledge of Cybermation (Job automation tool)->Should be familiar with Cybermation and be able to monitor/stop/start jobs in Cybermation
- Knowledge of Netezza SQL
- Filling process validation
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Validation Lead Job Description
Job Description Example
Our growing company is looking to fill the role of validation lead. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation lead
- Daily and Weekly status reporting
- Knowledge of conducting temperature mapping studies, including the operation of Kaye Data loggers or equivalent preferred
- Preparation of project plans, budgets and special assignments
- Author procedures, investigations, protocols, change controls, to support the Maintenance and Engineering departments
- Provide liaison between unit and customer executive management to ensure alignment of information services directions and business requirements
- Oversee contract validation services engineering projects (facilities, major equipment installations
- Evaluating computer system validation and system development life-cycle industry best practices and
- Challenge architects and design teams to improve product quality/compliancy
- Define how system or product requirement should be validated (test cases, hardware configuration, specifications and limitations)
- Define both hardware and software test set-up required to implement each test case
Qualifications for validation lead
- For filling, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPP’s and generate detailed validation protocol requirements and execution
- Visual Inspection in a Pharmaceutical Experience (Pharma Experience only)
- Must be proficient in E Doc with a working knowledge of templates, workflows and approval process
- Interact well with a diverse group of individuals
- Strong verbal / written and leaderships skills
- Flexible and team oriented, "can do" attitude
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Validation Lead Job Description
Job Description Example
Our company is looking to fill the role of validation lead. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation lead
- Optimize board design (performance vs cost trade off) with inputs from design and design-in teams
- Release Test set-up according to required capability (reproducibility and reproducibility) and test time
- Lead the product validation according to plan
- Ensure quality of team work – deliver on commitment
- Report/conclude on product and use case compliancy of the NXP product under test
- Support design-in team during result sharing meetings with customers
- Development of C&Q plans and input to scheduling activities for busy small projects group, in line with Novartis site standards for CQV
- Preparation and review of documents associated with lifecycle of C&Q activities for an API facility including Risk Assessments, DQ, IQ, OQ, IC and OC
- Oversight and implementation of the CQV Program, ensuring quality delivery
- Active participation with Client QA group to ensure compliance with procedures and provision of support to the QA Quality team in audit preparation
Qualifications for validation lead
- Limited exposure to DDR memory interface > 1Ghz - GDDR5/DDR3
- Basic understating high speed signaling principals and concepts related to design
- Multiphase switching power supply validation experience a strong plus
- Experience with previous ASIC PVT characterization
- Some exposure to various programming and scripting languages, C/C++ / Java Script, Linux
- High level of experience with the latest Tektronix and Agilent oscilloscopes along with strong debugging techniques to solve complex board level problems