C&Q Engineer – Filling Line

avril 23, 2024
Application ends: juin 23, 2024

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Job Description

Responsabilités :

  • Execute Commissioning & Qualification (C&Q) procedures for the Unloading Robotic system of the Filling line, adhering to established protocols and project documentation.
  • Develop and draft comprehensive C&Q protocols for the assigned package, ensuring timely review and approval of all associated documents.
  • Coordinate, manage, and oversee the entire C&Q process, from initial testing during Factory Acceptance Testing (FAT) to final Qualification acceptance.
  • Prepare and execute FAT and SAT protocols, ensuring alignment with equipment specifications and project requirements.
  • Conduct Design Qualification (DQ) protocol preparation, execution, and follow-up activities to ensure compliance with industry standards.
  • Perform Field Walkdowns of systems to facilitate the transfer of ownership from Construction, ensuring safe operation and functionality.
  • Manage nonconformities throughout the project lifecycle and prepare summary reports to document findings and resolutions.
  • Coordinate with contractors and vendors to facilitate project tasks and ensure seamless integration of systems.
  • Interface with various project stakeholders, including Construction, Engineering, Automation, Quality, and End Users, to address project needs effectively.
  • Collaborate with Automation contractors to support an integrated C&Q/CSV approach and provide regular status updates to the C&Q filling line Lead.

Exigences du Candidat :

  • Bachelor’s degree in Engineering or equivalent experience.
  • Minimum of 5 years of experience working in a pharmaceutical environment, preferably in sterile processes.
  • Extensive experience in C&Q, with significant expertise in the Qualification of Robotic equipment within the pharmaceutical context.
  • Proficient in GMPs, regulatory requirements, and equipment commissioning and qualification practices.
  • Strong written and verbal communication skills in both French and English, with the ability to engage effectively with technical and non-technical stakeholders.
  • Knowledge of KNEAT is advantageous for the position.

Soft Skills Requirements:

  • Demonstrated leadership and people management skills.
  • Effective communication skills to engage colleagues of various experience levels.
  • Ability to work collaboratively in a matrix environment and influence others.
  • Strong analytical and problem-solving skills to address challenges in a fast-paced setting.
  • Capacity to work independently and as part of a team to achieve project objectives.