Senior Validation Engineer - Remote & Impactful GMP Expert

BioSpace; San Diego (CA); On-site; USD 114,000 - 137,000; Full time

Job summary

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

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory compliance and internal quality standards. The role requires 7–11 years of biotech/pharma/medical device experience, strong cGMP knowledge, and expertise in IQ/OQ/PQ/CSV.

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of experience in biotech/pharmaceutical/medical device industry.
• Strong knowledge of FDA cGMP, FMEA, and risk-based validation.
• Experience writing IQ, OQ, PQ and CSV reports.

Responsibilities

• Lead generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated 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

FDA cGMP knowledge

Risk-based validation

Documentation & QA

Mentoring

Education

Bachelor’s degree in life sciences or engineering

Tools

CSV (Computerized Systems Validation)

Job description

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

You will develop, execute, and manage validation lifecycle documentation while ensuring regulatory compliance and internal quality standards. The role requires 7–11 years of biotech/pharma/medical device experience, strong cGMP knowledge, and expertise in IQ/OQ/PQ/CSV.