We are seeking a knowledgeable and detail-oriented Commissioning, Qualification, and Validation (CQV) Specialist to support the review, revision, and execution of CQV documentation for various pharmaceutical compression machines. The specialist will play a key role in ensuring that equipment qualification complies with current Good Manufacturing Practices (cGMP) and regulatory requirements, while aligning with internal quality standards.
Key Responsibilities:Review, revise, and update CQV documentation (URS, DQ, IQ, OQ, PQ) for multiple compression machines.
Perform gap assessments of existing qualification documents and identify areas for improvement or requalification.
Coordinate with cross-functional teams including Engineering, Manufacturing, Quality, and Maintenance to ensure alignment on equipment documentation and qualification strategy.
Ensure compliance with relevant industry standards and regulatory expectations including FDA, EU GMPs, ISPE Baseline Guides, and ASTM E2500.
Support the execution of qualification protocols and documentation of test results, deviations, and corrective actions.
Contribute to the preparation of final reports and regulatory submission documentation, as needed.
Maintain detailed and organized records that support audit readiness and project traceability.
Bachelor's degree in Engineering, Life Sciences, or a related technical field.
3+ years of experience in CQV within the pharmaceutical or biotech industry, preferably with exposure to solid dosage equipment.
Experience with compression machinery such as Fette, Korsch, Manesty, or equivalent.
Strong understanding of cGMP, 21 CFR Part 11, Annex 15, and validation lifecycle principles.
Skilled in technical writing and documentation review.
Ability to work independently and collaboratively in a fast-paced, regulated environment.
Excellent communication, organizational, and analytical skills.
Familiarity with quality systems and electronic document management tools (e.g., TrackWise, Veeva).
Knowledge of equipment automation or PLC systems is a plus.
Bilingual (English/Spanish) preferred for Puerto Rico-based roles.
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