Validation Engineer at BioSpace | Torre

Validation Engineer

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Full-time

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Boston, MA, USA
Shared by
Julien PETIT
3 months ago

Responsibilities


Company DescriptionA 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.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.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.Position OverviewSyner-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.Key Responsibilities(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 client projects, including generation, execution, review, and closure of validation life cycle documents.Write, review, and revise Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation 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 execution and closeout of validation work.Perform execution support activities including P&ID walkdowns, drawing reviews, and ETOP verification.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 RequirementsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The