Validation Engineer

Syner-G•Middletown, VA

5d•Remote

About The Position

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. 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

Requirements

Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field.
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.
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.
Must have current work authorization.
Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

Expertise in automated manufacturing environments, preferably within the life sciences or biopharma industry.
Experience in line layouts, fixture design, and 3D printing.
Preference for knowledge of filling and capping equipment.
Experience with high-speed fill-finish lines is a plus.

Responsibilities

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.