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: ContractStart Date: 1st JulyLocation: Stein, Canton AargauWorkload: 100%Work type: on siteDuration: 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.By applying for this position, I consent to the Swisslinx Group of companies:
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