C&Q Consultant
This position is based in the German speaking region of Switzerland.
The CQ Execution Coordinator is responsible for supporting the planning, execution and supervision of the Commissioning and Qualification field activities. To support meeting the agreed objectives regarding schedule and functionality according to URS, GMP, Safety and Environmental objectives including all relevant site local and global procedures. To support the implementation of strategy and Kneat platform.
Main Responsibilities
- Coordinating the planning and scheduling of commissioning and qualification activities with the construction interface, with the Building/ Building Services interface, and with other disciplines (Automation, Electrical, Instrumentation, User operation and Site engineering, etc.)
- Facilitate coordination execution meetings, providing an update on issues, risks and 'showstoppers'
- Support HSE matters
- Support overall field coordination of Commissioning & Qualification activities
- Support coordinating the commissioning field team including commissioning and qualification engineers, AEI experts, user and site engineers, document controllers and external vendors and contractors
- Support troubleshooting and resolution of commissioning related issues in a timely manner with CQ area leads
- Reviewing the commissioning test reports and ensuring their completeness post execution
- Ensuring the fulfilment of the pre-requisites prior to starting commissioning execution (Mechanical Completion, availability of tools, utilities, spares, document pre-requisites, etc.)
- Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging or integration
- Support document preparation including templates and execution scope according to CORP-35 & Kneat implementation
Requirements
- Strong knowledge and experience of Process Commissioning and Qualification.
- Management: Compliance with schedule at a system and area level with the planned resource levels.
- Safety: No lost time accident
- Experience in leading Commissioning and Qualification activities.
- Languages: German preferential. English - fluent in speaking and writing.
- Experience: Minimum 10 yrs.
- Proven experience, expert knowledge in ASTMe2500
- Kneat Power User
- Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing
Please reach out to me directly should you want to hear more about this position.
