CQV Lead

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16031en
  1. Contract
  2. English, German
  3. Mid-Senior level
  4. Engineering & Technical Services
  5. Basel Region
  6. Healthcare & Life Sciences

Skills

CQV, CSV, cross-functional collaboration, documentation, compliance, construction, management, Kneat, funktionsübergreifende Zusammenarbeit, Dokumentation, Compliance, Bau

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On behalf of our client, a leading international biotechnology company based in Visp, Swisslinx is looking for a CQV Lead. If this is you, you will be the lead for both CQV and CSV of a project to deliver a High Bay GMP warehouse for both cold and ambient temperatures.

Contract type: Contract
Start Date: 1st July
Location: Stein, Canton Aargau
Workload: 100%
Work type: on site
Duration: 12 months

Your mission as a CQV / CSV lead:
• Deliver a new drug product commercial building, alongside utilities, warehouse, and QC facilities.
• Interact closely with PM / Engineering / QA.
• Generate and plan the CQV / CSV timelines with CVQ / CSV manager and PM.
• Lead the assigned C&Q Team.
• Produce and manage key CQV deliverables, and engage with stakeholders and process users for review and approval cycle of deliverables.
• Manage, coordinate, and oversee supplier scope during design and construction phases.
• Review supplier documents for equipment and packages.
• Lead the bidding process for service providers scopes.
• Implement the company approach during the entire project.

The main responsibilities related to CQV / CSV scope will be:
• Execute and Coordinate CQV Activities: Ensure all commissioning, qualification, and validation activities comply with corporate and validation plans, including High Bay warehouse and key equipment.
• Lead and Support Testing: Lead testing activities with external vendors, generate and approve test scripts, and manage discrepancies.
• Collaborate Across Teams: Work with CSV, global IT, HSE, Automation, and Construction teams to address issues and ensure smooth execution.
• Manage Documentation and Reporting: Update validation plans, report C&Q status, and manage change control.
• Ensure Compliance and Safety: Adhere to company principles, maintain quality standards, and follow HSE guidelines.
• Support and Train Teams: Assist with handover processes, lead coordination meetings, and act as Kneat Super User (training provided).

Your background:
• 8+ years experience in areas/systems in this area.
• A relevant third level or professional qualification, preferably a diploma-level degree in Mechanical or Chemical Engineering.
• Languages: fluent English, fluent German would be an advantage.
• Previous experience authoring CQV lifecycle documents (necessary).
• Previous experience in qualifying a High bay warehouse (ambient and 2 to 8 degree cold room) (necessary).
• Considerable experience with cGMP.
• Field CQV execution experience.
• Proactive and working independently.
• Strong interpersonal and communication skills.
• Experience in use of Kneat for documentation development and execution.

What's on offer
• An initially 7 month contract, with planned extension.
• A great opportunity to develop your career at a leading international biotechnology company.

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