GMP Validation Lead & CSV Expert

Synerg; San Diego (CA); Remote; USD 115,000 - 130,000; Full time

Job summary

Syner-G in San Diego seeks a Senior Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, and GMP-regulated systems. This role develops, executes and manages validation lifecycle documentation while ensuring regulatory expectations and internal quality standards.

The position serves as a subject matter expert, supports complex projects, and provides guidance to junior team members, driving cross-functional collaboration and

Qualifications

• 7–11 years of experience in biotech, pharmaceutical, or medical device industries.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
• Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
• Experience generating validation protocols and reports, including IQ, OQ, PQ.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, and GMP-regulated assets.
• Oversee validation activities for internal and client tech transfer projects, including IQ/OQ/PQ and validation reports.
• Write and revise qualification and verification documents, including SOPs, validation master plans, URS/FRS, and test procedures.
• Prepare comprehensive summary reports for validation, verification, commissioning and requalification activities.
• Mentor junior validation staff and collaborate cross-functionally to align with project timelines.

Skills

Validation leadership

Regulatory knowledge

Documentation

Problem solving

Education

Bachelor’s degree in life science/engineering

Job description

Syner-G in San Diego seeks a Senior Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, and GMP-regulated systems. This role develops, executes and manages validation lifecycle documentation while ensuring regulatory expectations and internal quality standards.

The position serves as a subject matter expert, supports complex projects, and provides guidance to junior team members, driving cross-functional collaboration and