Validation Engineer II
this opportunity•Milford, MA
About The Position
The Validation Engineer II provides validation support for manufacturing and facility-related activities throughout the organization. The Validation Engineer II is responsible for general validation duties, including validation of facilities, utilities, equipment, mapping of cold rooms and of stability chambers, and support of Safety and Continuous Improvement efforts.
Requirements
- Bachelor of Science (BS) degree (Engineering preferred)
- Minimum of four + (4+) years of validation, manufacturing, or process engineering experience
- Knowledge of pharmaceutical unit operations, general mechanical/electrical engineering concepts, process and equipment design, and an understanding of GMP regulations.
Responsibilities
- Provide validation support to Manufacturing and Facilities
- Create Validation documentation including FATs, SATs, IQs, OQs, PQs, URDs
- Create and maintain Engineering documentation in support of validation projects including ETOPs and Engineering Drawings
- Develop and execute validation protocols
- Work with multi-department teams to coordinate and perform validation activities
- Lead validation deviation investigations
- Assist during the design, evaluation, and risk assessment of new computer systems, equipment, facilities, utilities, processes, and cleaning
- Assist during customer audits
- Participating in periodic review of validated systems, equipment, facilities, processes, and cleaning
- Performance and documentation of mapping studies for temperature-controlled storage and stability systems
- Participate in Safety and Continuous Improvement efforts to improve safety, efficiency and reduce cost
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
