CQV Engineer (a), Lucerne

International pharma company

18 months contract with extensionoption

About Our Client Our client is a well-established organization within the pharma industry, renowned for delivering innovative solutions and maintaining a strong commitment to quality and compliance. Operating as part of a large organization, the company fosters a professional and collaborative work environment.

Job Description 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.

The Successful Applicant 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.

What's on Offer

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.

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