Validation Engineer

Responsibilities

• (This list is not exhaustive and may be modified as needed.)
• Demonstrated experience supporting filling line and isolator qualification activities, including commissioning, validation, and lifecycle management.
• Strong understanding of industry best practices from 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 VanRx 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, fork truck operation, or fireman's license are considered a plus.
• QUALIFICATIONS AND REQUIREMENTS:
• Education
• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical preferred) or a related technical field.

Requirements

• 5-10 years of

Additional Information

COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here . Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com 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. WORK LOCATION: Travel to client sites may be required up to 100%, depending on project demands and client expectations.

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