Validation Engineer
Syner-G•Boston, MA
•Remote
About The Position
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.
Requirements
- 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.
Responsibilities
- 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&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.
Benefits
- market competitive base salary
- annual incentive plan
- robust benefit offerings
- ongoing recognition and career development opportunities
- generous flexible paid time off program
- company paid holidays
- flexible working hours
- fully remote work options for most positions
- ability to work “almost anywhere”
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
