Autoclave Project Manager

May 2, 2024
Application ends: July 2, 2024

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Job Description


Responsibilities:

  • Perform Commissioning & Qualification (C&Q) following GFD procedures, best practices, and project planning documents.
  • Prepare documents related to C&Q activities and execute FAT and SAT protocols.
  • Review equipment specifications to ensure compliance with FAT, SAT, and PIM requirements.
  • Develop Design Qualification (DQ) protocols and execute Qualification protocols (IQ, OQ, PQ).
  • Conduct field walkdowns of systems for transfer of ownership from Construction.
  • Ensure safe system operation during startup testing and Qualification phases.
  • Manage nonconformities throughout the project lifecycle.
  • Write summary reports and organize daily tasks and verifications.
  • Coordinate with contractors and vendors and interface with project team representatives.
  • Collaborate with Automation contractors to support integrated C&Q/CSV approach.
  • Provide weekly status updates to C&Q Material Preparation Lead.

Candidate Requirements:

Hard Skills:

  • Bachelor’s degree in Engineering or equivalent experience.
  • Minimum 5 years of experience in a pharmaceutical environment, preferably in sterile processes.
  • Extensive experience (minimum 5 years) in Commissioning & Qualification.
  • Significant experience in Qualification of Autoclave, Washer, or Component processor.
  • Good knowledge of GMPs, regulatory requirements, and equipment commissioning and qualification.
  • Significant experience in Commissioning & Qualification of Isolators packages.
  • Excellent written and verbal communication skills in both French and English.
  • Knowledge of KNEAT is a plus.

Soft Skills:

  • Clear and engaging communication with colleagues of varying experience levels.
  • Comfortable working in a matrix environment and persuading others.
  • Strong analytical and problem-solving skills.
  • Ability to thrive in a fast-paced environment.
  • Capable of working independently and collaboratively within a team.