Staftonic LLC
Validation Specialist (CQV) – Staftonic
Job Title: Validation Specialist (CQV)
Employment Type: Contract / Long-Term
Job Summary: 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.
Key Responsibilities
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.
Qualifications
Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related field.
3–6 years of CQV experience within pharmaceutical or biotech manufacturing.
Strong understanding of GMP and 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.
Seniority Level
Mid‑Senior level
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Employment Type: Contract / Long-Term
Job Summary: 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.
Key Responsibilities
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.
Qualifications
Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related field.
3–6 years of CQV experience within pharmaceutical or biotech manufacturing.
Strong understanding of GMP and 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.
Seniority Level
Mid‑Senior level
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