In this role, you will be responsible for overseeing and managing all Commissioning and Qualification (C&Q) activities related to utilities and equipment for the Fill and Finish processes. This encompasses a variety of systems, including a liquid and lyophilized vial filling line, isolators, and autoclaves. You will play a critical role in ensuring that all C&Q activities align with project requirements and industry standards.

Duration: Unlimited

Start Date: ASAP

Key Responsibilities

  • Ensure the execution of C&Q activities is in accordance with the C&Q Plan and supporting Validation Plans
  • Plan and oversee the commissioning activities for designated areas or systems
  • Lead and coordinate the C&Q execution efforts in collaboration with C&Q EPC teams, Engineering, Operations, and external contractors
  • Develop and maintain the schedule for commissioning activities based on the C&Q strategy and relevant Validation Plans
  • Assist in updating the Master C&Q Plan and supporting documentation throughout the project lifecycle
  • Contribute to the creation of the C&Q schedule by incorporating activities necessary for commissioning test plans and specifications
  • Coordinate the planning and scheduling of commissioning activities with construction interfaces and various disciplines, including HSE, Automation, Electrical, Instrumentation, Operations, and Engineering

Candidate Profile

  • At least 10 years of extensive experience in Commissioning and Qualification for Fill and Finish processes and associated utilities
  • Preferred qualification: Diploma in Mechanical or Chemical Engineering
  • Significant experience with both liquid and lyophilized vial filling lines
  • Strong understanding of the Pharmaceutical/Bio Science contract manufacturing sector with experience in cGMP
  • Proficient in assessing project-related resource requirements, timelines, and costs
  • Experience as a C&Q Lead and/or Project Manager
  • Hands-on experience in field C&Q execution
  • In-depth knowledge of cGMP standards
  • Excellent interpersonal and communication skills
  • Proficient in English, both written and spoken; German is a plus
  • Familiarity with Kneat for documentation development and execution is advantageous but not mandatory
  • Languages: Fluent in English (C1), German is a plus