We are currently looking for a CQV Engineer that will be responsible for ensuring that equipment, systems, and facilities are installed, qualified, and validated according to cGMP requirements. The role covers the full validation lifecycle, from drafting protocols to executing tests and documenting results, while supporting engineering and quality activities on site.
Responsibilities
* Coordinate equipment installation and prepare validation documentation including URS, DQ, FMEA, Risk Assessments, FAT/SAT, and IQ/OQ/PQ protocols.
* Execute IQ/OQ/PQ for equipment, systems, and utilities and document results in compliance with cGMP standards.
* Write reports for completed validation activities and ensure thorough, timely technical documentation.
* Perform GAP analyses, risk assessments, and contribute to continuous improvement of validation strategies.
* Ensure alignment with evolving regulatory requirements for equipment and facility validation.
* Support Quality Systems activities such as Document Management, Change Control, Non-Conformities, and CAPAs.
* Write or revise procedures related to engineering, validation, requalification, and maintenance programs.
* Collaborate with cross-functional teams and perform additional engineering or validation tasks as assigned.
* Fluent in German and English.
* Full-time onsite presence required in Visp.
* Bachelor’s degree in a scientific or technical discipline.
* 5–10 years of experience in the pharmaceutical industry with strong CQV exposure.
* Excellent technical writing skills and ability to produce accurate, compliant documentation.
* Strong communication, organizational, and time‑management abilities.
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