Senior Validation Engineer

1 week ago


framingham, United States Integrated Resources, Inc ( IRI ) Full time

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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