Senior Validation Engineer
2 weeks ago
Title: Principal Commissioning/Validation Engineer III
Location: Framingham, MA
Duration: 6 months
Work Schedule:
M-F 8AM-5PM
NOTE: Free Parking
Job Description:
- BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience.
- Experience in 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.
- Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems.
- Writes final reports.
- Resolves protocol discrepancies and deviations.
- Reviews 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
Areas of experience: plant utilities, clean utilities, CIP, SIP, Fill Finish, HVAC, Filling lines, CTUs
Top must-have skills: -
- Validation experience specific to pharma or biotech
- 4+ years of experience
Preferred/ Nice to Have skills:
Knowledge in data acquisition systems, such as Kaye - Preferred STEM Major
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