CQV Lead

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. Switzerland
Stein, Switzerland
Posting date: 14 May 2024
60386

Join the team and be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. We're seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.
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

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