Senior Commissioning Qualification Validation Engineer
3 weeks ago
Senior Commissioning Qualification Validation Engineer role at PSC Biotech Corporation. The Senior CQV Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility, and for the execution of the PSC mission, "to maintain the integrity and professionalism of our products and services while enabling steady growth and development."
Responsibilities- Act as a lead and simplify CQV functions, reports, and processes.
- Support implementing safety programs for major capital projects.
- Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
- Initiates, authors, revises, reviews, and completes controlled documents for CQV projects.
- Review and qualify equipment for commissioning, qualification, and validation activities.
- Writes and reviews GMP and GDP documents and technical specifications.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
- Contact and work with contractors and vendors on assigned projects.
- Ability to travel as needed.
- Additional duties and responsibilities may be assigned from time to time.
- 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.
- Proficient in developing SOPS, final reports and validation & quality policies.
- Strong experience developing and executing CQV protocols.
- Strong experience creating and maintaining CQV policies and processes.
- Has good understanding and complies to cGMPs and CFR21 Part 11 guidelines.
- Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate data to actionable plans.
- Excellent presentation and communication skills, written and oral.
- Highly organized in planning and time management, with the ability to multi-task.
- Mid-Senior level
- Full-time
- Quality Assurance
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