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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