Commissioning and Qualification (C&Q) Lead, Fill & Finish

at  Callista

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.

• 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 (cGMP).
• 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.