CQV Engineer (a), Lucerne

Firmenprofil 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.

Aufgabengebiet 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, and improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation such as SOPs, qualification/validation documents, and 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 for the entire site.

Represent TLE at 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 implementing process changes in the area and investigating root causes of deviations.

Evaluate innovative equipment/technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements.

Identify and harmonize practices across the site related to Qualification and Cleaning/Sterilization Validation– simplifying processing to ensure compliance while decreasing implementation effort.

Anforderungsprofil

A relevant degree in engineering, life sciences, or a related field.

5-8 years experience in the pharma industry, at least 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.

Vergütungspaket

An opportunity to work in the vibrant city of Lucerne within a leading science organization.

Exposure to cutting‑edge technologies and state‑of‑the‑art facilities.

A supportive and professional working environment.

Opportunities to develop and refine expertise in CQV processes.

Vertragsbedingungen 18 months contract with extension option.

Kontakt Referenznummer: JN-052026-7021723

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