Validation Engineer

Validation Engineer

Boston, Massachusetts, United States

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 Bio Space'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.

Syner-G is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.

Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re) qualification/(re) verification.

Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).

Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.

Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.

Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments.

Perform P&. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.

Support the resolution of regulatory observations or manufacturing site issues.

Execute periodic reviews and requalification for temperature chambers.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Bachelor's degree in a related life science field.

3-10 years of experience within the biotech, pharmaceutical, or medical device industry.

Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required.

Validation expertise in Equipment, CSV, Method, and Process.

Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation.

Report writing experience for IQ, OQ, PQ, and CSV.

Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired.

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.

The work…