Our partner is a global leader in life sciences that enables a healthier world by supporting companies in the pharmaceutical, biotechnology, and specialty ingredients markets. For our ongoing Project in Switzerland, we are seeking an experienced Commissioning and Qualification (C&Q) Lead to oversee critical C&Q activities related to utilities and equipment within the Fill and Finish area.

As the C&Q Lead for the Project, you will be responsible for planning, leading, and coordinating the commissioning and qualification (CQ) activities for a Liquid and Lyophilized vial filling line, including isolators and autoclaves. Reporting to the C&Q Manager, you will work closely with cross-functional teams, including Engineering, Operations, external vendors, and contractors, ensuring all CQ efforts are aligned with project timelines and regulatory standards.

Key Responsibilities:

• Lead CQ Activities:
  Oversee the execution of CQ activities as per the C&Q Plan and associated Validation Plans, ensuring compliance with project and regulatory standards (c GMP).
• Commissioning Execution:
  Plan, schedule, and manage the execution of commissioning activities for designated systems and areas, focusing on Fill and Finish utilities and equipment.
• Coordination:
  Lead and coordinate the efforts of internal C&Q teams, Engineering, Operations, and external vendors/contractors to ensure smooth execution of CQ activities.
• Schedule Management:
  Develop and maintain the project’s C&Q schedule, aligning it with overall project timelines and incorporating input from various teams such as Automation, Electrical, Instrumentation, HSE, and Engineering.
• Documentation Support:
  Assist in updating the Master C&Q Plan and support plans during the lifecycle of the project. Contribute to the development of commissioning test plans, specifications, and documentation.
• Interdisciplinary Collaboration:
  Coordinate commissioning activities with Construction, Health, Safety & Environment (HSE), Automation, and other relevant teams to ensure seamless project integration.

Candidate Profile:

• Experience:
  Minimum 10 years of hands-on experience in Commissioning and Qualification for Fill and Finish systems, including Liquid and Lyophilized vial filling lines, isolators, and autoclaves.
• Education:
  Diploma or degree in Mechanical or Chemical Engineering preferred.
• Industry Expertise:
  Deep understanding of c GMP requirements and extensive field CQV execution experience.
• Technical Knowledge:
  Familiarity with Kneat software for documentation development and execution is an advantage but not mandatory.
• Language Skills:
  Proficiency in English (written and spoken) is required. German language skills are a plus.
• Soft Skills:
  Excellent interpersonal and communication skills, with the ability to work effectively in a cross-functional team and manage external partners and vendors.

You will be part of a dynamic and innovative team working on the cutting-edge of pharmaceutical manufacturing. This is a unique opportunity to contribute to a high-impact project in a collaborative and growth-oriented environment. If this role sparks your interest, do not hesitate to reach out.