Senior Systems Validation Manager
1 week ago
Key Responsibilities:
- Lead and simplify CQV functions, reports, and processes.
- Implement safety programs for major capital projects.
- Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
- Initiate, author, revise, review, and complete controlled documents for CQV projects.
- Review and qualify equipment for commissioning, qualification, and validation activities.
- Write and review GMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
Requirements:
- Bachelor's Degree in Engineering or Life Science.
- 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry.
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Strong experience developing and executing CQV protocols.
- Good understanding and compliance with cGMPs and CFR21 Part 11 guidelines.
Job Title: Senior Commissioning, Qualification and Validation Engineer
The successful candidate will be responsible for ensuring that systems, facilities, and equipment meet design requirements.
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