(This list is not exhaustive and may be supplemented and changed as necessary.)
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 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&ID Walkdowns. 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.
QUALIFICATIONS AND REQUIREMENTS :
Education :
Bachelor's degree in a related life science field.
Technical Experience :
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.
Knowledge, Skills, and Abilities :
Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired.
ESSENTIAL FUNCTIONS :
Physical Demands :
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform
Additional Information
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 :
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.
Synerg · Boston, MA