Commissioning and Qualification
vor 4 Wochen
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 (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.
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 cGMP 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.
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