Katalyst CRO

Validation Engineer

Framingham, MA, US

5 months ago
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Summary

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.
  • 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.
  • Min Education Bachelor's degree.
  • plant utilities, clean utilities, CIP, SIP, Fill Finish, HVAC, Filling lines, CTUs .

Requirements

  • Validation experience specific to pharma or biotech - 7+ years of experience.
  • Knowledge in data acquisition systems, such as Kaye.
  • Preferred STEM Major.
  • plant utilities, clean utilities, CIP, SIP, Fill Finish, HVAC, Filling lines, CTUs, component prep equipment, formulation.
  • Well-developed communication skills, both verbal and written.
  • 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.

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