Biopharma C&Q Specialist — Field Validation Expert

Validation & Engineering Group; Temuco; Presencial; CLP 10.044.000 - 16.740.000; Jornada completa

Descripción de la vacante

Validation & Engineering Group, a Pinnaql company, is seeking C&Q Specialists to support equipment and systems in a biopharmaceutical facility. The specialists will execute field activities, document results, and work with project teams to complete system qualification.

Responsibilities include developing and executing commissioning and qualification protocols, performing FAT/SAT/IQ/OQ activities, reviewing drawings and vendor documentation, and coordinating with Engineering, Operations and

Formación

• 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.
• Strong field execution, technical writing and teamwork skills.

Responsabilidades

• 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.

Conocimientos

C&Q experience

Pharma/biopharma

Field execution

Technical writing

Teamwork

Descripción del empleo

Validation & Engineering Group, a Pinnaql company, is seeking C&Q Specialists to support equipment and systems in a biopharmaceutical facility. The specialists will execute field activities, document results, and work with project teams to complete system qualification.

Responsibilities include developing and executing commissioning and qualification protocols, performing FAT/SAT/IQ/OQ activities, reviewing drawings and vendor documentation, and coordinating with Engineering, Operations and