Commissioning and Qualification Manager

Vor 5 Tagen


Bern, Bern, Schweiz Capgemini Vollzeit
Job Description:

We are seeking an experienced Commissioning and Qualification Lead to join our team in Switzerland. As a key member of our team, you will be responsible for managing a team of engineers on high-profile client sites throughout the project lifecycle.

The ideal candidate will have strong experience with validation master plans, commissioning master plans, project procedures, and commissioning and qualification protocols. They will also be able to generate and execute system commissioning protocols, installation & operation qualification protocols, process qualification protocols, and identify the appropriate commissioning and qualification strategy.

Responsibilities include coordinating planning and scheduling of commissioning and qualification activities, preparing schedules, and reviewing progress. The successful candidate will have a BSc / MSc degree in Engineering, Chemistry, or a related field and at least 10 years of experience in commissioning and qualification activities for pharmaceutical facilities.

Key Responsibilities:
  • Manage team of C&Q Engineers on high profile client site throughout the project lifecycle.
  • Coordinating the planning and scheduling of commissioning and qualification activities.
  • Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT / Commissioning, IQ and OQ).
  • Generation and execution of the system commissioning protocols, installation & operation qualification protocols, process qualification protocols.
  • Identify the appropriate Commissioning and Qualification strategy.
  • Schedule preparation and progress review.
Requirements:
  • BSc / MSc Degree in Engineering, Chemistry or any related field.
  • 10+ years of experience in commissioning and qualification activities for pharmaceutical facilities.
  • Experience in leading Commissioning and Qualification activities.
  • Previous experience as manager / leader of C&Q team.
  • Strong knowledge and experience of Process Commissioning and Qualification.
  • Knowledge in qualification & validation approaches (especially ASTM E) is highly relevant.
  • Strong ability in Distributed Control System (DCS) and its interfaces, good knowledge of DeltaV.
  • Kneat Power User.
  • Fluency in English is required.


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