Commissioning and Qualification Specialist

il y a 4 jours

Paris, Île-de-France TMC Temps plein
Commissioning and Qualification Engineer - Pharma

We are seeking a highly skilled Commissioning and Qualification Engineer to join our team at TMC.

Main Responsibilities:
  • Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning documents.
  • Support C&Q activities and stay current on training of GFD procedures and Best Practices.
  • Develop Commissioning and Qualification Master Plan (CQMP) and system-specific plans, if required.
  • Develop System Level Impact Assessment document and component classification documents.
  • Review equipment specifications to ensure FAT, SAT, and PIM requirements are included, as appropriate.
  • Facilitate and document Design Reviews and Design Qualifications.
  • Support FAT and SAT activities and perform receipt verification for components and equipment delivered to site.
  • Develop and execute commissioning documentation, including installation verification, start-up, loop checks, initial calibration, and functional testing.
  • Develop and execute IQ and OQ documentation.
  • Collaborate with Automation contractors in support of integrated C&Q/CSV approach.
  • Provide monthly status and budget updates to C&Q Lead using C&Q monthly report template.
Requirements:
  • BS Engineering (or equivalent experience).
  • 5 years working in pharmaceutical environment and if possible, in sterile process.
  • 10 years C&Q experience.
  • Demonstrated leadership and people management skills.
  • Knowledge of GMP's, regulatory requirements, equipment commissioning, and qualification.
  • Good written and verbal communication skills with both technical and non-technical staff (French + English).

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