Biopharma C&Q Specialist - Field Execution & Validation

Pinnaql, Inc.; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group seeks a C&Q Specialist to support equipment and systems in a biopharmaceutical facility. You will execute field activities, document results, and work with project teams to complete system qualification.

The role requires hands-on field work, protocol development, and rigorous documentation in GMP environments. Candidate must have strong technical writing skills and be able to coordinate with Engineering, Operations, and Quality to turnover systems.

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.
• Strong field execution technical writing and teamwork skills.

Responsibilities

• 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.

Skills

C&Q expertise

GMP knowledge

Technical writing

Teamwork

Field execution

Tools

FAT

IQ/OQ

SAT

Job description

Validation & Engineering Group seeks a C&Q Specialist to support equipment and systems in a biopharmaceutical facility. You will execute field activities, document results, and work with project teams to complete system qualification.

The role requires hands-on field work, protocol development, and rigorous documentation in GMP environments. Candidate must have strong technical writing skills and be able to coordinate with Engineering, Operations, and Quality to turnover systems.