Validation Specialist; CQV

Job Description

We’re seeking a CQV Validation Specialist to perform commissioning, qualification, and validation (CQV) of process equipment, utilities, and facilities for a regulated pharmaceutical manufacturing site. The ideal candidate will have hands‑on experience with IQ/OQ/PQ, cleaning validation, and temperature mapping in GMP environments.

• Execute and author IQ/OQ/PQ protocols for equipment, utilities, and facilities per the Validation Master Plan (VMP).
• Perform temperature mapping for controlled areas, storage units, and process systems.
• Support cleaning validation, develop MACO calculations, perform swab/rinse sampling, and review analytical results.
• Lead and review validation documentation including protocols, reports, and risk assessments.
• Collaborate with Engineering, QA, and Manufacturing during commissioning and qualification activities.
• Support change controls, deviations, and CAPA related to validated systems.
• Participate in validation reviews and contribute to continuous improvement of site validation practices.

• Bachelor’s degree in engineering, Biotechnology, Life Sciences, or related field.
• 36 years of CQV experience within pharmaceutical or biotech manufacturing.
• Strong understanding of GMP, FDA guidelines.
• Hands‑on experience in equipment and cleaning validation, including utilities such as WFI, clean steam, and HVAC.
• Proficiency in temperature mapping tools (e.g., Kaye Validator or equivalent) preferred.

Mid‑Senior level

Contract

Quality Assurance

Pharmaceutical Manufacturing