Senior Validation Engineer - Remote, GMP & CSV Expert

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

Job summary

Syner-G in San Diego seeks a Sr. Validation Engineer with 7–11 years of biotech/pharma experience to lead validation across equipment, utilities, facilities, and computerized systems in GMP environments.

You will develop, execute and manage validation lifecycle documentation, mentor junior staff, and collaborate cross-functionally to ensure regulatory compliance and timely project delivery. The role requires strong knowledge of IQ/OQ/PQ, FAT/SAT, risk assessments, and CSV; candidate will lead

Qualifications

• 7–11 years of experience in the biotech, pharmaceutical, or medical device industry.
• 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.
• Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
• Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and remediation activities.

Responsibilities

• Lead generation and execution of validation lifecycle documents (FAT, SAT, IOQ, PQ) for GMP assets.
• Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
• Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• 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.

Skills

Verbal & written communication

Documentation & record-keeping

Leadership of validation workstreams

Problem solving & root cause analysis

Mentoring junior staff

Cross-functional collaboration

Education

Bachelor's degree in life science or engineering

Tools

CSV (Computerized Systems Validation)

FMEA

Validation protocols

IQ/OQ/PQ execution

Job description

Syner-G in San Diego seeks a Sr. Validation Engineer with 7–11 years of biotech/pharma experience to lead validation across equipment, utilities, facilities, and computerized systems in GMP environments.

You will develop, execute and manage validation lifecycle documentation, mentor junior staff, and collaborate cross-functionally to ensure regulatory compliance and timely project delivery. The role requires strong knowledge of IQ/OQ/PQ, FAT/SAT, risk assessments, and CSV; candidate will lead