Senior Validation Engineer — Remote GMP Impact

BioSpace; San Diego (CA); On-site; USD 115,000 - 130,000; Full time

Job summary

Syner-G is seeking a Sr. Validation Engineer to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes in GMP environments.

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory alignment and quality standards. The role requires 7–11 years in biotech/pharma/medical devices and hands-on experience with IQ/OQ/PQ, CSV, and regulatory audits.

Qualifications

• 7–11 years of biotech, pharmaceutical, or medical device validation experience.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation.
• Experience writing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits and regulatory inspections.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ).
• Oversee validation activities for internal and client tech transfer projects, including drafting and closing validation documents.
• Write, review, and revise qualification and verification documents (SOPs, validation master plans, URS, FRS, design specs).
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Develop procedures, investigations, protocols, and reports for Maintenance, Engineering, and Quality functions.
• Lead P&ID walkdowns to verify installation and system readiness.
• Perform and oversee thermal mapping of temperature-controlled chambers and SIP processes.
• Support regulatory observations and audit findings related to validation.
• Lead periodic reviews and requalification of validated assets.
• Provide mentorship to junior validation staff.

Skills

FDA cGMP knowledge

Validation lifecycle

Mentoring

Documentation

Cross-functional collaboration

Education

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

Job description

Syner-G is seeking a Sr. Validation Engineer to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes in GMP environments.

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory alignment and quality standards. The role requires 7–11 years in biotech/pharma/medical devices and hands-on experience with IQ/OQ/PQ, CSV, and regulatory audits.