avril 17, 2024
Application deadline closed.

Job Description

Responsabilités :

  • Execute Commissioning & Qualification (C&Q) activities for Component processors, Autoclave, and Washer, adhering to project planning documents, procedures, and specifications.
  • Develop and draft all supporting C&Q documents and protocols for the assigned package, ensuring timely review and approval.
  • Coordinate, execute, and complete C&Q activities from initial testing during Factory Acceptance Testing (FAT) to final Qualification acceptance.
  • Prepare FAT, Site Acceptance Testing (SAT), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
  • Conduct field walkdowns and ensure safe operation of systems during testing and Qualification phases.
  • Manage nonconformities throughout the project lifecycle and prepare summary reports.
  • Organize and track daily tasks, verify progress, and coordinate with contractors/vendors.
  • Interface with project team representatives, Construction, Engineering, Automation, Quality, and End Users during project phases.
  • Collaborate with Automation contractors to support an integrated C&Q/CSV approach.
  • Provide weekly status updates to the C&Q Material Preparation Lead.

Hard Skills Requirements:

  • Bachelor’s degree in Engineering or equivalent experience.
  • Minimum 5 years of experience in the pharmaceutical environment, preferably in sterile processes.
  • At least 5 years of C&Q experience.
  • Significant experience in Qualification of Autoclave, Washer, or Component processor.
  • Proficiency in GMPs, regulatory requirements, equipment commissioning, and qualification.
  • Significant experience in Commissioning & Qualification of Isolator packages.
  • Strong written and verbal communication skills in both French and English.
  • Knowledge of KNEAT is advantageous.

Soft Skills Requirements:

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