Validation Engineer at Syner-G BioPharma Group

Waltham, Massachusetts, United StatesFull-timeFacilities OperationsPosted 23 days ago

About the Role

<div class="content-intro">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 <a href="https://www.youtube.com/watch?v=2rUMvtncuw8">here</a>.  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 <a id="menur1aj1" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="https://www.synergbiopharma.com/" target="_blank">www.Synergbiopharma.com</a></div>  <div> 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.   <div> WORK LOCATION: Travel to client sites may be required up to 100%, depending on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be modified as needed.)   <div> <ul> <li>Demonstrated experience supporting filling line and isolator qualification activities, including commissioning, validation, and lifecycle management.</li> <li>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.</li> <li>Capable of drafting, executing, and finalizing CQV documentation for standard equipment and systems (e.g., IQ/OQ/PQ protocols, summary reports, and traceability matrices).</li> <li>Experienced in developing and facilitating risk assessments (e.g., FMEA), ensuring appropriate mitigation strategies and alignment with regulatory expectations.</li> <li>Able to assume ownership of existing CAPAs (Corrective and Preventive Actions) and Change Controls (CCs), effectively driving them through investigation, implementation, and closure.</li> <li>Preferred experience working with VanRx robotic isolator systems, including qualification, troubleshooting, or operational support.</li> <li>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.</li> <li>Suitable for a Facilities GMP Technical role, with flexibility to travel between Boxborough and Watertown sites (approximately 2 days per week at each location).</li> <li>Hands-on troubleshooting experience with both facility infrastructure and process systems, including root cause analysis and implementation of corrective actions.</li> <li>Familiarity with Building Management Systems (BMS) and BMRAM or similar computerized maintenance/asset management platforms.</li> <li>Willingness to participate in an on-call rotation to support facility and process needs as required.</li> <li>Ability and willingness to obtain a specialty boiler license (if not already certified).</li> <li>Additional certifications such as wastewater operation, fork truck operation, or fireman’s license are considered a plus.</li> </ul> </div>   <div> QUALIFICATIONS AND REQUIREMENTS: Education <ul> <li>Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical preferred) or a related technical field.</li> </ul> Experience <ul> <li>5–10 years of experience in CQV, validation engineering, facilities engineering, or a blended role.</li> <li>Strong experience supporting GMP utilities, cleanroom environments, and facility systems.</li> <li>Experience with commissioning and qualification of facility and utility systems.</li> <li>CAPEX project experience is preferred.</li> </ul> Knowledge, Skills, and Abilities <ul> <li>Strong understanding of CQV lifecycle and validation principles.</li> <li>Knowledge of GMP regulations (FDA, EMA) and data integrity requirements.</li> <li>Experience with utilities and infrastructure systems in regulated environments.</li> <li>Familiarity with ISPE guidance and ASTM E2500 is preferred.</li> <li>Strong troubleshooting, root cause analysis, and problem-solving skills.</li> <li>Ability to develop and interpret engineering and validation documentation.</li> <li>Excellent communication, leadership, and collaboration skills.</li> <li>Highly organized and capable of balancing project-based work with ongoing operations support.</li> </ul> ESSENTIAL FUNCTIONS: 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.  Work Environment:  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.  TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. </div> </div> </div> LEGAL STATEMENT:   Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

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