Senior Commissioning Engineer
3 weeks ago
Position: Principal Commissioning/Validation Engineer III, Req#: SNFIJP00008706
Location: Framingham, MA (100% onsite)
Duration: 6 Months Contract
Job Description:
Education and Experience:
- BSc/BEng plus previous experience in the CQV field or equivalent combination of education and experience.
- Experience in the pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
- Areas of experience: plant utilities, clean utilities, CIP, SIP, Fill Finish, HVAC, Filling lines, CTUs, component prep equipment, formulation.
- Well-developed communication skills, both verbal and written.
- Years of Experience: 6 - 9 Years.
- Excellent oral and written communication
- Ability to effectively manage time and prioritize tasks independently
- Excellent organizational skills
- Ability to manage day-to-day operations in a fast-paced environment
- Ability to effectively manage several tasks simultaneously
- Must be self-motivated and have a proven ability to work in a team environment
Roles and Responsibilities:
- Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems
- Writes final reports
- Resolves protocol discrepancies and deviations
- Review vendor-generated validation protocol packages.
- Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practices.
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