CQV Lead

vor 4 Wochen

Stein AG, Schweiz Swisslinx Vollzeit
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.


By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA

I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)

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