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CSV Project Lead
2 months ago
Job Title: CSV Project Lead
Location: New Hampshire MA
Duration: 12 months plus
Job Description:
- 10 years of experience in Computer Systems Validation
- Strong knowledge in validation lifecycle of Facilities Utilities Process Equipment Computerized Systems and Analytical Instruments
- Familiarity with biologics (mammalian CGT) and chemical manufacturing technologies is desirable
- Provide necessary training for project CSV engineers
- Lead the project
- Serve as the Lead Engineer / Liaison for the C&Q and CSV Teams
- Support C&Q / CSV lifecycle and testing document reviews and approvals throughout the project
- Provide technical SME input for document development and testing activities
- Drive resolution of testing incidents engineering changes and automation changes
- Support management of CSV project controls and progress reporting
- Assist C&Q manager in developing/updating CSV timeline throughout the project
- Strong knowledge of Software Development Lifecycle (SDLC) including 21CFR part 11/Annex 11 and Data Integrity
- Provide high-level guidance/strategy for CSV activities
- Review and approve CSV Documentation (URS FS DQ IV/IQ OV/OQ OPQ and Summary Reports) as required
- Provide CSV oversight on engineering change controls and automation changes
- Experience working independently as well as in a team-oriented collaborative environment
- Experience with Kneat is essential
- Strong verbal and written communication skills
- Support projects during regular work hours with some overtime as needed
Education & Experience:
- 10 years of experience in Computer Systems Validation
Required Skills:
- CSV Project Lead
- Computer Systems Validation
- Kneat
- Automation