CQV Qualification Lead

Set up as a new job alert
  1. Contract
  2. English
  3. Mid-Senior level
  4. Engineering & Technical Services
  5. Basel Region
  6. Healthcare & Life Sciences


CQV, Qualification, CQV Lead, Mechanical Engineering, Chemical Engineering, cGMP, C&Q

Click here to get a notification every time a job like this gets added

Great news! We will let you know when a new job like this has been added!

This vacancy has now expired
On behalf of our client, an international Pharmaceutical company based in Switzerland, Swisslinx is looking for a CQV Qualification Lead. This is a 12-months contract position (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.

The CQ Lead is responsible for overseeing the defined CQ scope of his process area and meeting the agreed objectives regarding time schedule and functionality according to URS, Risk Assessments and Verification Plans. The C&Q Lead will act as representative for C&Q execution scope under responsibilities of third parties C&Q EPC(s).

Start Date: October 2023
Duration: 12 months with possible extension
Location: Zurich area
Workload: 100%

Your mission:

- CUB and PU Buildings Black Utilities: Instrument Air, Black Steam reduction and distribution Systems, Chilled and Cooling Water Systems, Sanitary systems, Drinking/Heating water systems, etc.
- PU Building Clean Utilities: Compressed Air, Nitrogen, Softened Water, Purified water system, Clean Steam Generation and Distribution, WFI Generation and Distribution.
- HVAC and Clean Rooms (all buildings)
- Warehouse and QC Buildings Utility distribution systems (Clean and Black Utilities)

Main responsibilities:
- Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans
- Overall planning and execution of the commissioning activities related to allocated areas or systems
- Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
- Planning and scheduling the commissioning activities according to the C&Q strategy and supporting Validation Plans
- Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle
- Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
- Coordinating the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)
- Guiding the C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems
- Lead the preparation activities for commissioning activities start-up
- Coordination and interfacing with vendors for C&Q execution related activities. Also ensuring the execution is completed in accordance with CORP-35 principles.
- Guiding and overall oversight of the Commissioning field execution, including protocols execution. Coordinating the interface of test specifications
- Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties
- Reporting of C&Q status, progress and issues during 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 adequately reviewed and approved in accordance with CORP-35. Tracking of these deficiencies, including planning and executing the remediation actions
- Assist the C&Q Manager with the Handover and Release process
- Leads 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
C&Q execution milestones are completed as per baseline schedule
- Ensurs C&Q field execution is completed in a safely manner and following HSE standards. This will include overall oversight of Lock-Out-Tag-Out preparation, PSHR completion, Method Statements, and Start-up activities
- Participate in construction walk-downs and punch-listing of these systems for Mechanical Completion
- Ensure that quality standards are followed during C&Q execution

Your profile:

- A relevant Third Level or Professional Qualification
- Ability to work well under pressure and within strict deadlines
- Minimum of 10 Years extensive experience in areas/systems under future responsibility
- Preferably Diploma level degree in Mechanical or Chemical Engineering
- 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 (not mandatory)

For further information or to apply please do not hesitate to contact Alina Peeva, Senior Recruiter: alina.peeva@swisslinx.com or press "apply now" below.

How to nurture your top consultancy talent

Researcher is dropping the reagent into test tube.Scientist working at the laboratory.

5 life science trends that are reshaping the Swiss market