Senior Commissioning Engineer

Found in: Appcast Linkedin GBL C2 - 3 weeks ago


Framingham, United States TalentBurst, an Inc 5000 company Full time

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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