Validation Engineer

Syner-G•San Diego, CA

4d•Remote

About The Position

Syner-G is seeking a Senior 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 Senior Validation Engineer serves as a subject matter expert, supports complex technical projects, and guides junior team members. The position supports internal and client technology-transfer projects and works across Maintenance, Engineering, Quality, and other functions to align validation activities with project timelines and operational needs. Responsibilities include authoring, executing, reviewing, and closing validation and qualification documents; supporting audits, inspections, and remediation; and leading requalification and periodic-review activities. The role requires a bachelor’s degree in a life science, engineering, or related technical field and 7–11 years of experience in the biotech, pharmaceutical, or medical device industry. The work environment is described as a typical office environment with moderate noise, an indoor temperate setting, and bright lighting. The position offers fully remote work options for most positions; the posting also lists office locations in Greater Boston, San Diego, Boulder, and India.

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.
Ability to use a computer keyboard and mouse; reach with hands and arms; talk and listen; frequently walk and sit; lift and carry objects up to 25 pounds; and occasionally stand, stoop, or kneel.
Close vision and the ability to adjust focus.

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 ensure validation activities align with project timelines and operational needs.