Principal Commissioning/Validation Engineer III
2 weeks ago
Title: Principal Commissioning/Validation Engineer III
Location: Framingham, MA (Only local candidates)
Job Duration: 7 Months (Contract)
Note: Only for candidates local to Framingham, MA and willing to transfer H1b can apply.
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. Well-developed communication skills, both verbal and written.
Essential Duties and Responsibilities:
- 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
Other Skills and Abilities:
- 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
Top must-have skills:
Validation experience specific to pharma or biotech - 4+ years of experience, willing to accept more years of experience.
Local candidates only Areas of experience: plant utilities, clean utilities, CIP, SIP, Fill Finish, HVAC, Filling lines, CTUs, Free parking onsite.
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