Validation Engineer

Syner-G • San Diego, CA

2d • $110,000 - $125,000 • Remote

About The Position

Syner-G is seeking a Sr. Validation Engineer to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes in GMP-regulated environments. The role develops, executes, and 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 involves validation work for internal and client technology-transfer projects, preparation and review of qualification and verification documents, thermal mapping, periodic reviews, requalification, and support for regulatory observations, audits, and manufacturing-site issues. The role collaborates across functions to align validation work with project timelines and operational needs.

The position may be performed fully remotely, with flexible working hours and the option to work from office locations in Greater Boston, San Diego, Boulder, or India. The typical office environment is indoors, temperate, and moderately noisy. Physical tasks include computer use, walking, sitting, reaching, talking, listening, and occasionally standing, stooping, or kneeling; lifting and carrying objects weighing up to 25 pounds is also required.

The expected salary range is $110,000 to $125,000 per year. Pay depends on experience, qualifications, geographic location, and other job-related factors. Syner-G is unable to sponsor or take over sponsorship of an employment visa at this time.

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 organization, 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 generation and execution of validation lifecycle documentation, including FAT, SAT, IOQ, and PQ, for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated assets.
• Oversee validation activities for internal and client technology-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.

Benefits

• Market-competitive base salary and annual incentive plan.
• Robust benefits offerings.
• Generous flexible paid time off program.
• Company-paid holidays.
• Flexible working hours.
• Fully remote work options for most positions and the ability to work “almost anywhere.”
• Ongoing recognition and career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior