Sr. Validation Engineer

Company Overview

Syner‑G is a strategic biopharma product development and delivery partner that enables its people to build careers that positively impact quality of life. The company accelerates breakthrough science and delivery of life‑enhancing therapies, working across diverse clients from drug discovery through commercialization. Syner‑G has been honored with BioSpace’s “Best Places to Work” award for three consecutive years, reflecting its commitment to culture, career growth, financial rewards, leadership, and innovation.

About the Role

The Sr. Validation Engineer (7‑11 years experience) will lead and support validation activities for equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms in GMP‑regulated environments. The role involves developing, executing, reviewing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations, data integrity, and internal quality standards. The engineer will act as a subject‑matter expert for validation and computerized systems, providing QA/Validation oversight for MES and eBR implementations.

Key Responsibilities

• Generate and execute validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, computerized systems, and other GMP‑regulated assets.
• Provide QA/Validation oversight for MES and eBR implementation, qualification, and system lifecycle activities.
• Review and approve requirements, risk assessments, traceability matrices, validation plans, test protocols, deviations, change controls, and validation summary reports.
• Review eBR workflows and electronic manufacturing processes to ensure alignment with approved procedures, master batch records, and GMP requirements.
• Ensure compliance with 21 CFR Part 11, GMP, data integrity, CSV, and industry best practices.
• Support deviation investigations, CAPAs, change controls, system releases, and go‑live readiness for MES/eBR and other GMP computerized systems.
• Oversee validation activities for internal and client technology transfer projects, authoring, executing, reviewing, and closing validation documentation.
• 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 validation, verification, commissioning, qualification, and requalification summary reports.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, Manufacturing, 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 and computerized systems.
• Lead periodic reviews and requalification activities for validated equipment, systems, and temperature‑controlled assets.
• Collaborate closely with Manufacturing, Validation, Automation, IT/OT, Quality, and project teams to align validation activities with timelines and operational requirements.
• Provide technical mentorship and guidance to junior validation staff and project team members.

Qualifications and Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
• 7‑11 years of experience in biotechnology, pharmaceutical, or medical device industry.
• Strong knowledge of FDA cGMP requirements, risk‑based validation methodologies, and quality system requirements.
• Advanced validation expertise in equipment qualification, process validation, CSV, and automation systems.
• Experience supporting MES and eBR validation, implementation, qualification, or lifecycle management in GMP manufacturing.
• Proven ability to review and approve validation documentation (protocols, reports, requirements specifications, risk assessments, traceability matrices, deviations).
• Extensive experience generating and executing IQ, OQ, PQ, CSV, and system qualification documentation.
• Experience supporting audits, regulatory inspections, remediation activities, and quality system compliance initiatives.
• Familiarity with MES platforms such as PAS‑X, PharmaSuite, Syncade, Opcenter, or similar systems (strongly preferred).

Knowledge, Skills, and Abilities

• Deep understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity, and CSV methodologies.
• Demonstrated MES/eBR validation and qualification experience in regulated environments.
• Excellent technical writing, documentation review, and validation reporting skills.
• Strong verbal and written communication; ability to collaborate across Manufacturing, Quality, Validation, Automation, Engineering, and IT/OT.
• Highly organized with strong analytical, problem‑solving, and investigation abilities.
• Capability to lead validation workstreams, manage multiple priorities, and work independently in a fast‑paced setting.
• Experience supporting deviation investigations, root cause analysis, CAPAs, and change management.
• Ability to mentor junior engineers and contribute to team development and knowledge sharing.

Essential Functions

Physical Demands: Regular use of computer keyboard and mouse; frequent walking, sitting, and lifting objects up to 25 lb; occasional standing, stooping, or kneeling; close vision and ability to adjust focus.

Work Environment: Moderate noise level, indoor temperature‑controlled setting, bright lighting conducive to minimal eye strain; typical office environment.

Total Rewards

Syner‑G offers a market‑competitive base salary, annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees enjoy generous flexible paid time off, company‑paid holidays, flexible working hours, and fully remote work options for most positions, with the ability to work “almost anywhere.” Office locations are available in Greater Boston, San Diego (CA), Boulder (CO), and India for those preferring a physical workspace. The company currently does not sponsor employment visas.