Biopharma Validation Engineer | IQ/OQ/PQ & Remote

BioSpace; Boston (MA); Hybrid; USD 90,000 - 150,000; Full time

Benefits offered by this job

Remote work options

Office locations in Greater Boston

Job summary

Syner-G is seeking a Validation Engineer to drive validation programs across processes and equipment in a biotech/pharma setting. You will develop and execute validation life cycle documents, ensuring compliance with quality systems and regulatory requirements.

The role emphasizes collaboration with project teams to maintain robust validation practices and formal reporting. The position requires hands-on validation experience, strong documentation skills, and the ability to operate within a

Qualifications

• 3–10 years of experience in biotech, pharmaceutical, or medical device industries.
• Knowledge of FDA cGMP, FMEA, and Risk Analysis required.
• Expertise in Process Equipment, Utilities, Clean Room validation.
• Hands-on equipment start-up and troubleshooting experience.
• Report writing experience for IQ, OQ, PQ.

Responsibilities

• Generate and execute validation life cycle documentation (FAT, SAT, IOQ, PQ) for various processes and systems.
• Support validation activities for client projects, including generation, execution, review, and closure of validation life cycle documents.
• Write, review, and revise Installation, Operation, and Performance qualification/verification related documents (URS/FRS/etc.).
• Write reports to summarize validation/verification/commissioning activities.
• Write procedures, investigations, protocols, and change controls to support validation work.
• Perform P&ID walkdowns, drawing reviews, and ETOP verification.
• Perform thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations or manufacturing site issues.
• Execute periodic reviews and requalification for temperature chambers.

Skills

FDA cGMP

FMEA

Risk Analysis

Process Equipment Validation

Utilities Validation

Clean Room

IQ/OQ/PQ Reporting

Communication

Education

Bachelor's degree in a related life science field

Job description

Syner-G is seeking a Validation Engineer to drive validation programs across processes and equipment in a biotech/pharma setting. You will develop and execute validation life cycle documents, ensuring compliance with quality systems and regulatory requirements.

The role emphasizes collaboration with project teams to maintain robust validation practices and formal reporting. The position requires hands-on validation experience, strong documentation skills, and the ability to operate within a