Senior Validation Engineer: GMP Systems & Tech Transfer Lead

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

Benefits offered by this job

Remote work options

Flexible PTO

Company-paid holidays

Job summary

Syner-G, a biopharma product development partner in San Diego, seeks a Sr. Validation Engineer to lead validation across equipment, utilities, facilities and manufacturing processes in GMP environments.

You will develop, execute and manage validation lifecycle documentation and mentor junior staff. The role requires 7–11 years in biotech/pharma, strong FDA cGMP knowledge, and proven ability to prepare IQ/OQ/PQ, risk assessments, and validation reports while collaborating with cross‑functional

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of biotech/pharma/medical device experience.
• 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 IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and remediation activities.

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

Leadership

Regulatory knowledge

Documentation

Communication

Problem solving

Education

Bachelor's degree in life sciences or engineering

Tools

CSV

Job description

Syner-G, a biopharma product development partner in San Diego, seeks a Sr. Validation Engineer to lead validation across equipment, utilities, facilities and manufacturing processes in GMP environments.

You will develop, execute and manage validation lifecycle documentation and mentor junior staff. The role requires 7–11 years in biotech/pharma, strong FDA cGMP knowledge, and proven ability to prepare IQ/OQ/PQ, risk assessments, and validation reports while collaborating with cross‑functional