C&Q Manager

Description

C&Q Manager



Our global pharmaceutical client is searching for a C&Q Manager to support them on the construction of a new manufacturing facility. Reporting to the Project Director, the Commissioning and Qualifications Leader will be responsible for the entire Commissioning and Qualification (C&Q) program from the design stages to completion of qualification.



Location:             Frankfurt region, Germany

Duration:             3 year project, 1 year initial contract

Rate:                     € all-inclusive daily rate



Responsibilities will include:



- Define strategy for C&Q full lifecycle; testing; facility start-up; documentation and regulatory compliance.

- Definition of manufacturing systems including: strategy for design phases; testing strategy and lists; sequence for startup.

- Develop the project C&Q master plan, identify task lists and project timelines in line with the project objectives and goals. Ensure compliance to client and regulatory best practice.

- Lead the C&Q cost, resource and schedule planning and control process.

- Interface with the other project teams to develop the overall C&Q phase project plan and schedule which includes risk assessment, design review/DQ, test matrix, FAT, SAT/commissioning, installation, operational and performance qualification for all systems.

- Lead the C&Q team (technical writers, commissioning engineers, interfaces to calibration and system owners) and manage day-to-day project C&Q activities.

- Responsible for project C&Q documentation development and management, and quality of the documentation library.

- Work closely with the Construction Management team to align the C&Q program with the construction program

- Manage and close major deficiencies (punch list and exceptions list) in timely manner.



Requirements:



- Experience as the C&Q manager / responsible of a manufacturing construction project in the (bio)pharmaceutical industry is essential.

- Experience with current C&Q methods and industry best practice.

- Excellent problem solving and troubleshooting abilities.

- Ability to work in a fast paced environment.

- Experience with working in project environment (€ >100 million)

- This individual should be a self-starter with strong interpersonal, organizational, and technical skills. Capability to work both independently and in a team environment.

- Must be able to establish strong working relationships with team members and other stakeholders.



- Strong people management skills. Must be able to lead a team in the execution of C&Q activities.