C&Q Specialist – Field Validation for Pharma/Biopharma

Pinnaql, Inc.; Washington (District of Columbia); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Validation & Engineering Group Inc. seeks a C&Q Specialist to support equipment and systems in a biopharmaceutical facility in the Washington, DC area.

You will develop, review and execute commissioning and qualification protocols, perform field walkdowns, and coordinate with Engineering, Operations and Quality to turnover systems. The role requires 5+ years of C&Q experience in pharma/biopharma, familiarity with FAT/SAT/IQ/OQ, and strong GMP knowledge with controlled documentation.

Qualifications

• At least 5 years of C&Q experience in a pharmaceutical or biopharmaceutical facility.
• Experience with FAT/SAT IQ/OQ or comparable commissioning and qualification activities.
• Working knowledge of GMP requirements and controlled documentation.

Responsabilités

• Develop, review and execute commissioning and qualification protocols.
• Perform field walkdowns, installation verification and functional testing.
• Review drawings, specifications and vendor documentation against installed systems.
• Document test results, investigate discrepancies and support corrective actions.
• Coordinate with Engineering, Operations and Quality to complete qualification and system turnover.

Connaissances

C&Q experience

GMP knowledge

Technical writing

Field execution

Teamwork

Description du poste

Validation & Engineering Group Inc. seeks a C&Q Specialist to support equipment and systems in a biopharmaceutical facility in the Washington, DC area.

You will develop, review and execute commissioning and qualification protocols, perform field walkdowns, and coordinate with Engineering, Operations and Quality to turnover systems. The role requires 5+ years of C&Q experience in pharma/biopharma, familiarity with FAT/SAT/IQ/OQ, and strong GMP knowledge with controlled documentation.