Job Description
The CQ Coordinator reports to the Project CQV Manager and is responsible for supporting the planning, execution, and supervision of Commissioning and Qualification field activities. The role ensures compliance with the URS, GMP, Safety and Environmental objectives and all relevant site/local and global procedures.
* Coordinating the planning and scheduling of commissioning and qualification activities with the construction interface, Building/Building Services interface, and other disciplines (Automation, Electrical, Instrumentation, User operation, Site engineering, etc.)
* Facilitate coordination execution meetings, providing updates on issues, risks, and ‘showstoppers’
* Support HSE matters in:
o Implementation of HSE Plan and PTW procedures
o Awareness training & implementation of LOTOTO and Safe Work Method Statements/Risk Assessments
o Audits with support from HSE manager
* Support overall field coordination of Commissioning & Qualification activities:
o With CQV Manager and Workstream CQV Leads – Schedule, Priorities and Execution Matters
o With CQ Qualification Lead – Lifecycle and Test documentation readiness
o With Project Quality – Quality matters, Incidents, ECN
o With Automation – Field Automation issues / readiness
o With Construction – for Mechanical Completions
o With Technical Package Leads – System Readiness, troubleshooting
o Schedule forecasting
* 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
* Support the investigation, implementation & closure of deficiencies and deviations
* Review commissioning test reports and ensure their completeness post execution
* Ensure prerequisites (Mechanical Completion, tools, utilities, spares, documents, etc.) are fulfilled before starting commissioning execution
* Ensure sufficient safety training for all involved personnel
* Perform daily coordination meetings to fine‑tune the commissioning execution with all parties involved
* Ensure compliance of commissioning activities with qualification requirements where test results are subject to leveraging or integration
* Support document preparation including templates and execution scope internal guidelines for COMOS & Kneat
Skills
* Kneat Power User
* Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing
* Excellent written and oral communications and interpersonal and influencing skills
* Experience working in a global environment
* Experience in pharmaceutical projects using Engineering, Procurement, Construction and Commissioning type contracts
* Strong analytical skills – ability to conduct analysis of complex/large data sets, draw conclusions accordingly, and support decisions
* Able to deal with ambiguity – can conform to shifting priorities and demands
* Ability to effectively prioritize and execute tasks in a fast‑paced environment
Seniority level
* Mid‑Senior level
Employment type
* Contract
Job function
* Pharmaceutical Manufacturing
Location: Stein, Aargau, Switzerland
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