CQV Engineer (a)

The CQV engineer will be responsible for the following tasks:

• Lead/Supervise site projects related to Qualification, CSV, Cleaning/Sterilization Validation:
• Lead coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.
• Responsible for the development / review / improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation: such as SOPs, qualification/validation documents, reports.
• Responsible for compliance deliverables and technical deliverables related to qualification and validation.
• Act as an SME and point of contact for Qualification and Cleaning/Sterilization Validation at the entire Site.
• Represent TLE at both local site meetings and cross functional global meetings.
• Represent Qualification and Cleaning/Sterilization Validation aspects during inspections.
• Provide direction, give guidance and implement procedures in agreement with TLE Lead.
• Responsible for the area's implementation of process changes, and root cause investigation of deviations.
• Responsible for the evaluation of innovative equipment / technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements.
• Identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation - simplifying processing to ensure compliance, while decreasing implementation effort.

A successful candidate should have:

• A relevant degree in engineering, life sciences, or a related field.
• 5-8 years experience in the pharma industry, min 2 years in computer system validation, equipment qualification and cleaning validation.
• Proficiency in English; additional language skills are an advantage.
• Experience in Change and Deviation Management
• Familiarity with GMP regulations and related quality standards.
• Excellent problem-solving abilities and attention to detail.
• Capability to work collaboratively within a cross-functional team.

Our client offers you:

• An opportunity to work in the vibrant city of Lucerne within a leading LIFE SCIENCE organization.
• Exposure to cutting-edge technologies and state-of-the-art facilities.
• A supportive and professional working environment.
• Opportunities to develop and refine your expertise in CQV processes.

If you are ready to take the next step in your career as a CQV ENGINEER, we encourage you to apply and join a team that values excellence and innovation.