C&Q Engineer – Dispensing & Aux Equipment

May 7, 2024
Urgent
Application ends: July 7, 2024

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Job Description

Responsibilities:

  • Develop and execute Commissioning & Qualification (C&Q) documentation for the new aseptic cartridge filling capacity project, focusing on dedicated Dispensing and auxiliary equipment.
  • Coordinate, execute, and complete C&Q activities from initial testing during FAT to final Qualification acceptance of assigned packages.
  • Prepare and review all C&Q protocols, ensuring timely approval and adherence to project timelines.
  • Perform FAT and SAT protocols, and review equipment specifications to ensure compliance with project requirements.
  • Conduct Design Qualification (DQ) protocol preparation, execution, and follow-up.
  • Conduct field walkdowns of systems to ensure safe operation and transfer of ownership from Construction.
  • Manage nonconformities throughout the project lifecycle and prepare summary reports.
  • Organize and track daily tasks/verifications to ensure progress and completion of assigned activities.
  • Coordinate with contractors and vendors and interface with project team representatives during all project phases.
  • Collaborate with Automation contractors to support an integrated C&Q/CSV approach.
  • Provide weekly status updates to C&Q Formulation Lead.

Candidate Requirements:

Hard Skills:

  • Bachelor’s degree in Engineering or equivalent experience.
  • Minimum 5 years of experience in the pharmaceutical industry, preferably in sterile processes.
  • Minimum 5 years of experience in Commissioning & Qualification.
  • Good knowledge of GMPs, regulatory requirements, and equipment commissioning and qualification.
  • Significant experience in Commissioning & Qualification of CIP/SIP & COP/SOP packages.
  • Excellent written and verbal communication skills in both French and English.
  • Knowledge of KNEAT software is a plus.

Soft Skills:

  • Demonstrated leadership and people management skills.
  • Effective communication skills with colleagues of various levels of experience.
  • Comfortable working in a matrix environment and ability to persuade others.
  • Strong analytical and problem-solving abilities.
  • Ability to thrive in a fast-paced environment and work both independently and as part of a team.