Duration:
- 12 months plus
Job Description:
- CSV experience of 10+ years
- Strong knowledge in validation lifecycle of Facilities, Utilities, Process Equipment, Computerized Systems and Analytical Instruments.
- Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable.
- Provide any necessary training as required for the project CSV engineers.
- Leading the project
- Serve as the overall 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 course of project.
- Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11and 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 oversite on engineering change controls and automation changes
- Experienced at working independently as well as in a team-oriented, collaborative environment is essential
- Experience with Kneat is needed
- Strong verbal and written communication skills
- Support projects during regular work hours with some overtime as needed.
Required Skills:
- CSV Project Lead
- Computer Systems Validation
- Kneat
- Automation
NH: CSV Project Lead (235248)
