Sr. Validation Engineer

Syner-G•San Diego, CA

7h•$114,000 - $137,000•Remote

About The Position

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-regulated environments. The role manages validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The engineer serves as a subject matter expert, supports complex technical projects, and guides junior team members. The position supports internal and client tech transfer projects and works across Maintenance, Engineering, Quality, and other functions to align validation activities with project timelines and operational needs. Work may involve validation, verification, commissioning, and requalification activities, as well as audits, regulatory inspections, and manufacturing-site issues. Syner-G describes its total rewards program as including a market-competitive base salary and annual incentive plan, benefits, recognition, career development, flexible paid time off, company-paid holidays, flexible working hours, and fully remote work options for most positions. The role's expected salary range is $114,000 to $137,000 yearly.

Requirements

Bachelor’s degree in a life science, engineering, or related technical field.
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.
Strong verbal and written communication skills, including the ability to explain complex technical concepts to diverse audiences.
Strong organizational, documentation, and analytical skills.
Ability to lead validation workstreams, manage multiple priorities, and work independently.
Strong problem-solving skills and experience supporting investigations and root-cause analysis.
Ability to mentor junior engineers and contribute to team development.

Responsibilities

Lead the 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 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 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 align validation activities with project timelines and operational needs.