Validation Engineer

About the role

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 : We are seeking a hands-on Validation Engineer with a strong background in mechanical or manufacturing engineering, who brings expertise in automated manufacturing environments, preferably within the life sciences or biopharma industry. This role combines engineering document reviews, equipment startup support, and process/manufacturing engineering with project management and cross-functional communication responsibilities. The ideal candidate will have experience in line layouts, fixture design, and 3D printing, with a preference for knowledge of filling and capping equipment. While this is not a controls engineering role, familiarity with PLCs and HMIs is required. The role also involves managing smaller projects and collaborating across teams to ensure successful execution in GMP-regulated environments. Proficiency in AutoCAD and SolidWorks is essential. WORK LOCATION : Travel to client sites may be required up to 100%, depending on project demands and client expectations. KEY RESPONISIBILITIES : Perform equipment qualifications including Commissioning, IQ, OQ, and PQ. Provide hands-on engineering support during equipment startup and validation activities. Conduct engineering document reviews and contribute to process improvement initiatives. Write, review, approve, and execute validation protocols and reports. Lead and mentor a small team of CQV engineers. Collaborate with scientists, technicians, engineers, and project managers to deliver validated equipment and facilities. Ensure validation programs meet GMP, FDA, and ISO standards. Support design and execution of verification tests and validation strategies. Coordinate with cross-functional teams and vendors to meet project milestones. Contribute to layout planning and fixture design, leveraging 3D printing where applicable. Communicate effectively across disciplines to define requirements and deliver solutions. QUALIFICATIONS & REQUIREMENTS: Education : Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field. Technical Experience : 5-7 years of experience in biotech, pharmaceutical, or medical device industries. Strong understanding of GMP, FDA regulations, FMEA, and risk analysis. Experience with validation disciplines including Equipment, CSV, Method, and Process. Skilled in protocol generation and validation of automated production systems. Proficient in AutoCAD and SolidWorks. Familiarity with PLCs, HMIs, and automated manufacturing systems. Experience with high-speed fill-finish lines is a plus. Skills and Abilities : Strong leadership and project management skills. Excellent communication and stakeholder engagement across functions. Ability to manage vendors and contractors effectively. Hands-on approach to engineering and problem-solving. Willingness to travel up to 100% for client site projects. 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 en

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