Senior Validation Engineer - GMP Equipment & Systems Lead

Synerg; Raleigh (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Fully remote work options

Total rewards program

Job summary

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience 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, support audits and regulatory findings, and mentor junior team members to ensure quality and compliance. This role offers remote-friendly options and a total rewards program, with cross‑functional collaboration

Qualifications

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

Responsibilities

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

Skills

FDA cGMP

FMEA

Risk-based validation

IQ/OQ/PQ/CSV reports

Education

Bachelor’s degree in life science or engineering

Job description

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience 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, support audits and regulatory findings, and mentor junior team members to ensure quality and compliance. This role offers remote-friendly options and a total rewards program, with cross‑functional collaboration