CQV Lead

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Key responsibilities

• LEAD for CQV and CSV scope of Process Support Bldg (comprising of a High Bay GMP warehouse both cold and ambient temperatures).
• The client is currently looking for a Commissioning and Qualification Lead to meet the needs for the Dolphin Project at the existing Novartis AG site (GETEC Park) in Stein (AG), Switzerland.
• The project will deliver a new DP commercial building alongside Utilities, Warehouse and QC facilities.
• The CQ Engineer is responsible for driving the execution and coordination of the defined CQ scope of his/her process area and meeting the agreed objectives regarding time schedule and functionality according to URS, Risk Assessments and Verification Plans. The C&Q Engineer will support the C&Q lead for execution scope under responsibilities of third parties.
• Role of a CQV/CSV-Lead on Dolphin project in Stein involves:
  • Interaction with PM / Engineering / QA
  • Generating and Planning the CQV/CSV timelines with CQV/CSV manager and PM
  • Close interaction with Process Engineers, PM and QA
  • Leading the assigned C&Q Team
  • Producing and managing key CQV deliverables and engaging with stakeholders and Process users for review and approval cycle of deliverables
  • Managing, coordinating and overseeing supplier scope during design and construction phases
  • Reviewing supplier documents for equipment and packages
  • Leading the bidding process for service providers scopes
  • Implementing the clients CORP-35 CQV Approach during the entire project
• Ensure that CQV activities are executed in accordance with CORP 35, the C&Q Plan and supporting Validation Plans.
• C&Q SME for High Bay warehouse scope - cold and ambient (high preference).
• Support C&Q execution for key main eqpt (Semiautomated and fully automated visual inspection machine), other small support equipment in Building 413 (LAF, thawing units, fridges, freezers, cold /freezer rooms, etc.), including alignment with execution approach of equivalent systems in QC building.
• Execution of the commissioning activities related to allocated areas or systems.
• Coordination of execution activities with supporting CSV Team and global IT teams.
• Lead C&Q testing activities supported by external vendors and/or contractors
• Develop any supporting validation plans related to scope of execution.
• Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
• Interface and with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.
• Ensure the execution is completed in accordance with CORP-35 principles
• Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties
• Maintain and reporting of C&Q status, which can be reported into project stakeholders meetings (e.g. Tier 1 meetings, Wall meetings).
• Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.
• Ensure discrepancies encountered are developed, adequately reviewed and approved in accordance with CORP-35. Tracking of these deficiencies, including planning and executing the remediation actions
• Assist the C&Q Lead with the Handover and Release process.
• Lead the management of change for his area elements and ensures that the change is controlled, communicated and implemented in the most cost effective and timely manner
• Ensure C&Q execution milestones are completed as per baseline schedule
• C&Q field execution completed in a safely manner and following the clients HSE standards. This will include preparation of Lock-Out-Tag-Out, PSHR completion, Method Statements, and Start-up activities.
• Liaising with Construction on design and construction issues.
• Participate in construction walk-downs and punch-listing of these systems for Mechanical Completion.
• Ensure that quality standards are followed during C&Q execution. No significant observations in external regulatory inspections for allocated process area.
• Support the C&Q execution team as Kneat Super User (super user training can be provided).

Requirements

• A relevant Third Level or Professional Qualification
• Ability to work well under pressure and within strict deadlines
• Minimum of 8 Years extensive experience in areas/systems under future responsibility.
• Preferably Diploma level degree in Mechanical or Chemical Engineering.
• Previous experience in authoring CQV lifecycle documents necessary
• Previous experience in qualifying a High bay warehouse (ambient and 2 to 8 degree cold room) necessary
• Proactive and working independently
• Field CQV execution experience.
• Considerable experience with cGMP
• Strong interpersonal and communication skills.
• Good Level in English, written and spoken / German a plus.
• Experience in use of Kneat for documentation development and execution

S.Hubert@Proclinical.com
DL: +44 203 949 8594
CH: +41 61 508 7073
Mob: +44 7592 053 700