Remote CQV Project Engineer (Biopharma GMP)
Syner G
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Job summary
Syner-G is seeking experienced Project Engineers to support IQ/ CQV activities in GMP biopharmaceutical environments. You will develop, execute IQ protocols for bioreactors, media hold tanks and related systems, ensuring proper installation and documentation.
The role requires IQ/CQV expertise, strong technical writing, and collaboration with Engineering, QA, Validation, and vendors to achieve system turnover readiness and regulatory compliance.
Qualifications
- 3+ years in CQV or Validation within GMP environments.
- Experience developing and executing IQ protocols for process equipment.
- Experience qualifying bioreactors, media systems, tanks, and utilities.
- Familiarity with GMP documentation practices and GDP.
Responsibilities
- Develop, review, and execute IQ protocols for bioreactors and related equipment.
- Verify installation against P&IDs and engineering specs.
- Perform field walkdowns, inspections and verification activities.
- Identify and resolve qualification discrepancies and punch items.
- Collaborate with Engineering, QA, Validation and vendors for turnover readiness.
- Maintain qualification documentation for regulatory inspections and audits.
- Communicate project status and risks to stakeholders.
Skills
Education
Tools
Job description
Syner-G is seeking experienced Project Engineers to support IQ/ CQV activities in GMP biopharmaceutical environments. You will develop, execute IQ protocols for bioreactors, media hold tanks and related systems, ensuring proper installation and documentation.
The role requires IQ/CQV expertise, strong technical writing, and collaboration with Engineering, QA, Validation, and vendors to achieve system turnover readiness and regulatory compliance.
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