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C&q lead fill & finish (m/f/d)

Hays – Stein (6170)

Contract: Uren: Salaris:

Job description

C&Q Lead Fill & Finish

(m/f/d)

Freelance/temporary employment for a project Stein Start date: asap Reference number: 839236/1

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Responsibilities

  • Lead and coordinate CQ execution for Fill and Finish facility systems
  • Manage commissioning activities for filling, semi-stoppering, isolators, lyophilizers, and stopper treatment stations
  • Ensure alignment with C&Q and Validation Plans throughout project lifecycle
  • Develop and maintain commissioning schedules and test specifications
  • Collaborate with EPC teams, Engineering, Operations, and external vendors
  • Support updates to Master C&Q Plan and related documentation
  • Oversee HVAC systems, H2O2 decontamination processes, and glove integrity testing
  • Coordinate with construction and other disciplines (HSE, Automation, Electrical, etc.)
  • Ensure proper documentation and execution of commissioning protocols
  • Monitor and report progress, risks, and mitigation strategies
  • Profile

  • Experience in CQ for Fill and Finish and related utilities
  • Diploma or higher degree in Mechanical or Chemical Engineering preferred
  • Proven expertise in liquid and lyophilized vial filling technologies
  • Strong understanding of cGMP and contract manufacturing environments
  • Experience in project planning, resource estimation, and cost control
  • Prior roles as CQV Lead and/or Project Manager
  • Hands-on field CQV execution experience
  • Excellent interpersonal and communication skills
  • Fluent in English (written and spoken); German is a plus
  • Familiarity with Kneat for documentation (preferred but not mandatory)
  • Benefits

  • Opportunity to lead critical CQ activities in a high-impact project
  • Work in a dynamic, cross-functional team environment
  • Exposure to cutting-edge pharmaceutical manufacturing technologies
  • Competitive compensation and project-based incentives