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COMPUTER SYSTEMS VALIDATION (CSV) ENGINEER
Durham, NC 27713 United States
Under the supervision of the Manager of Data Systems and Compliance, this position will serve as a member of the information technology team supporting (currently) five biopharmaceutical manufacturing facilities in the U.S. and Canada. Based in the RTP area of North Carolina, the position will be responsible for providing Quality Control reviews (QC) supporting IT applications / systems development for SDLC deliverables. The CSV engineer will provide compliance guidance for GxP and Non-GxP software releases.
- Plan and manage validation projects while meeting regulatory requirements and project schedule.
- Provide guidance to the creation and review of SDLC documentation.
- Review Test Scripts & outputs and other documentation to ensure that all steps have been executed
correctly, and that verify tests cover all requirements.
- Review validation documentation and test summary reports to ensure compliance.
- Review of created Test Plans, Test Cases, and Test Scripts based on the requirements specification.
- Review Test Error Reports, verify solutions are feasible and content accuracy.
- Assist in working with the IT Operations and Application Management team(s) and providing review of
- Contribute to long-term planning for the Systems Validation business model including team goals, metrics,
and resource needs.
- Follow directives and standards on quality assurance testing and documentation.
- Provide training, technical support, and documentation of information systems to peers and end users.
- Routinely communicate status (tasks, test coverage, problems encountered and time remaining to
complete) to the team and stakeholders.
- Other responsibilities as assigned by the Manager of Data Systems and Compliance
- Work closely with internal and external teams to provide the necessary design, configuration, deployment,
and support during the implementation of the company’s computer system
- Validation documentation creation and development including GxP Assessments, Validation Plans, Risk
Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, and Standard
- Managing Vendor Installations and Vendor Validation Documentation
- Test Execution and Deviation Management
- Ability to plan and schedule completion of Validation Lifecycle deliverables with little supervision
- Ability to anticipate problems/issues and create contingency plans
- Business acumen required to evaluate technical priorities and tasks against business and budgetary constraints
- Exceptional written and verbal communication skills
- Demonstrated success working through language and cultural differences
- Experience working within a regulatory/compliance/best practice framework such as ITIL, GxP/GMP, etc
- Aptitude to quickly understand various IT and Pharmaceutical disciplines at a moderately complex level
- The employee is occasionally required to stand, up to 6 hours a day; walk; reach with hands/arm & stoop,
kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.
- 2+ years of software testing or validation experience.
- Experience working in a GxP Life Sciences environment for Computer Systems Validation (CSV).
- Experience with GAMP5, 21 CFR Part 11 and Annex 11
- Experience working with Agile development and SDLC.
- Excellent verbal and written communication skills.
- Project Management experience
- French Fluency is a plus
Technical degree with a minimum of 9 years’ experience or Bachelor degree with a minimum of 7 years’ experience or equivalent.
Some travel may be required.
North Carolina Biotechnology Center