Senior Validation Engineer – GMP/CSV Lead

synerg; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, and computerized systems in GMP‑regulated environments. This role develops, executes, and manages validation lifecycle documentation while ensuring regulatory compliance and quality standards.

The Sr. Validation Engineer will act as a subject matter expert, support complex projects, and mentor junior staff, collaborating with cross‑functional teams to

Qualifications

• 7–11 years of experience in biotech, pharmaceutical, or medical device industries.
• Strong knowledge of FDA cGMP requirements, risk-based validation, and FMEA.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning, and shipping systems.
• Oversee validation activities for internal and client tech transfer projects; author, execute, review, and close validation documents (IQ, OQ, PQ, risk assessments, validation plans).
• Write, review, and revise qualification and verification documents (SOPs, validation master plans, URS, FRS, design specs, commissioning tests).
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Lead P&ID walkdowns to verify installation, configuration, and system readiness.
• Perform and oversee thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Lead periodic reviews and requalification activities for temperature-controlled systems and other validated assets.
• Provide technical mentorship and guidance to junior validation staff.
• Collaborate cross-functionally to ensure validation activities align with project timelines and operational needs.

Education

Bachelor's degree in a life science, engineering, or related technical field

Tools

Computerized systems validation (CSV)

Job description

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, and computerized systems in GMP‑regulated environments. This role develops, executes, and manages validation lifecycle documentation while ensuring regulatory compliance and quality standards.

The Sr. Validation Engineer will act as a subject matter expert, support complex projects, and mentor junior staff, collaborating with cross‑functional teams to