Validation Engineer at Syner-G BioPharma Group

Middletown, Virginia, United StatesFull-timeGMP & OperationsPosted about 1 month 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> 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: <ul> <li>Perform equipment qualifications including Commissioning, IQ, OQ, and PQ.</li> <li>Provide hands-on engineering support during equipment startup and validation activities.</li> <li>Conduct engineering document reviews and contribute to process improvement initiatives.</li> <li>Write, review, approve, and execute validation protocols and reports.</li> <li>Lead and mentor a small team of CQV engineers.</li> <li>Collaborate with scientists, technicians, engineers, and project managers to deliver validated equipment and facilities.</li> <li>Ensure validation programs meet GMP, FDA, and ISO standards.</li> <li>Support design and execution of verification tests and validation strategies.</li> <li>Coordinate with cross-functional teams and vendors to meet project milestones.</li> <li>Contribute to layout planning and fixture design, leveraging 3D printing where applicable.</li> <li>Communicate effectively across disciplines to define requirements and deliver solutions.</li> </ul> QUALIFICATIONS & REQUIREMENTS: Education: <ul> <li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field.</li> </ul> Technical Experience: <ul> <li>5–7 years of experience in biotech, pharmaceutical, or medical device industries.</li> <li>Strong understanding of GMP, FDA regulations, FMEA, and risk analysis.</li> <li>Experience with validation disciplines including Equipment, CSV, Method, and Process.</li> <li>Skilled in protocol generation and validation of automated production systems.</li> <li>Proficient in AutoCAD and SolidWorks.</li> <li>Familiarity with PLCs, HMIs, and automated manufacturing systems.</li> <li>Experience with high-speed fill-finish lines is a plus.</li> </ul> Skills and Abilities: <ul> <li>Strong leadership and project management skills.</li> <li>Excellent communication and stakeholder engagement across functions.</li> <li>Ability to manage vendors and contractors effectively.</li> <li>Hands-on approach to engineering and problem-solving.</li> <li>Willingness to travel up to 100% for client site projects.</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. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.   LEGAL STATEMENT:   Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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.

About the Role

About the Role

Related Roles

About the Role

Related Roles