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Senior Commissioning Engineer - Framingham, United States - TalentBurst
Description
Position:
Principal Commissioning/Validation Engineer III ,
Req#:
SNFIJP
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: - 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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