Validation Engineer

Position Overview

Syner‑G is seeking a Validation Engineer with 5–10 years of experience supporting and leading commissioning, qualification, validation, and ongoing operation of GMP facility systems across laboratory, manufacturing, and utility environments.

This role combines facilities engineering ownership (utilities, maintenance, infrastructure) with CQV lifecycle execution, ensuring that facility systems are designed, commissioned, qualified, maintained, and compliant with GMP and regulatory expectations.

The Validation Engineer will act as a technical subject matter expert across facility systems, lead validation efforts, support lifecycle management, mentor junior staff, and collaborate cross‑functionally to ensure safe, reliable, and inspection‑ready operations.

Travel to client sites may be required up to 100%, depending on project demands and client expectations.

• Demonstrated experience supporting filling line and isolator qualification activities, including commissioning, validation, and lifecycle management.
• Strong understanding of industry best practices a Commissioning, Qualification, and Validation (CQV) perspective, with the ability to apply these principles in regulated GMP environments.
• Capable of drafting, executing, and finalizing CQV documentation for standard equipment and systems (e.g., IQ/OQ/PQ protocols, summary reports, and traceability matrices).
• Experienced in developing and facilitating risk assessments (e.g., FMEA), ensuring appropriate mitigation strategies and alignment with regulatory expectations.
• Able to assume ownership of existing CAPAs (Corrective and Preventive Actions) and Change Controls (CCs), effectively driving them through investigation, implementation, and closure.
• Preferred experience working with Van Rx robotic isolator systems, including qualification, troubleshooting, or operational support.
• Proficient in executing and supporting revalidation activities across a range of GMP equipment, including Controlled Temperature Units (CTUs), isolators, bioreactors, TFF and chromatography systems, and critical utility systems.
• Suitable for a Facilities GMP Technical role, with flexibility to travel between Boxborough and Watertown sites (approximately 2 days per week at each location).
• Hands‑on troubleshooting experience with both facility infrastructure and process systems, including root cause analysis and implementation of corrective actions.
• Familiarity with Building Management Systems (BMS) and BMRAM or similar computerized maintenance/asset management platforms.
• Willingness to participate in an on‑call rotation to support facility and process needs as required.
• Ability and willingness to obtain a specialty boiler license (if not already certified).
• Additional certifications such as wastewater operation, forklift operation, or fireman’s license are considered a plus.

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical preferred) or a related technical field.

• 5–10 years of experience in CQV, validation engineering, facilities engineering, or a blended role.
• Strong experience supporting GMP utilities, cleanroom environments, and facility systems.
• Experience with commissioning and qualification of facility and utility systems.
• CAPEX project experience is preferred.

• Strong understanding of CQV lifecycle and validation principles.
• Knowledge of GMP regulations (FDA, EMA) and data integrity requirements.
• Experience with utilities and infrastructure systems in regulated environments.
• Familiarity with ISPE guidance and ASTM E2500 is preferred.
• Strong troubleshooting, root cause analysis, and problem‑solving skills.
• Ability to develop and interpret engineering and validation documentation.
• Excellent communication, leadership, and collaboration skills.
• Highly organized and capable of balancing project‑based work with ongoing operations support.

Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable…