CQV Specialist – Upstream Process Equipment & Downstream Biotech Process Equipment
On-site · Boston, Massachusetts, United States or Caguas, Caguas, Puerto Rico
Job Summary
CQV Specialist responsible for developing, reviewing, and executing IQ/OQ/PQ qualification and validation protocols for upstream and downstream biotech process equipment; participate in installation, start-up, and commissioning projects; review and approve technical documentation including manuals, procedures, and validation reports; collaborate with Engineering, Operations, and QA/QC to ensure regulatory compliance; identify risks and opportunities for process and equipment improvement; provide support during internal and external audits; maintain CQV records in line with industry standards. Preferred skills include CQV/Process Validation, Project Management certifications, and experience with fermentation, chromatography, filtration, or downstream process systems; proficiency with AutoCAD, TrackWise, and Veeva.
Required Qualifications
- Bachelor’s degree in Chemical Engineering, Biochemistry, Biotechnology, or related field
- Minimum 3–5 years of experience in commissioning, qualification, and validation of biotech process equipment (both upstream and downstream)
- Strong knowledge of GMP, FDA, cGMP, and international regulatory requirements
- Hands-on experience developing and executing IQ, OQ, and PQ protocols
- Excellent teamwork, communication, and problem-solving skills
- Proficiency in technical documentation software and validation tools (e.g., AutoCAD, TrackWise, Veeva)
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