CQV Lead (M/F/D)

CQV Lead (M/F/D)

Tasks:
Reporting to the Project CQV Manager.
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 in:
Implementation of HSE Plan and PTW procedures
Awareness training & implementation of LOTOTO and Safe Work Method Statements/Risk Assessments
Housekeeping
Audits with support from HSE manager
Support overall field coordination of Commissioning & Qualification activities:
With CQV Manager and Workstream CQV Leads– Schedule, Priorities and Execution Matters
With CQ Qualification Lead – Lifecycle and Test documentation readiness
With Project Quality - Quality matters, Incidents, ECN
With Automation – Field Automation issues  / readiness
With Construction – for Mechanical Completions
With Technical Package Leads – System Readiness, trouble shooting
Support look-ahead schedule
Support measurement of ‘Actual’ progress
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
Support schedule remediation activities
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 sufficient safety training for all involved persons
Performing daily coordination meetings to fine-tune the commissioning execution with all involved parties
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
 
Qualification:
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.
 
Requirements: 
Start: asap / march
Duration: 12months
Capacity: 5 days per week
Location: Switzerland