Commissioning & Qualification Engineer
For our client, an international biopharmaceutical company, active in the fields of reproductive health, urology, gastroenterology, endocrinology, and orthopaedics, we are looking for a Commissioning & Qualification Engineer.
For our client, an international biopharmaceutical company, active in the fields of reproductive health, urology, gastroenterology, endocrinology, and orthopaedics, we are looking for a Commissioning & Qualification Engineer.
Join our team and play a pivotal role in enhancing and maintaining the quality standards for our operations and products. This opportunity, situated within a rejuvenating project, focuses on enhancing: - Pharmaceutical process equipment- Cleanroom facilities- Process and non-process utilities- Infrastructure As the primary point of contact for commissioning and qualification (C&Q) endeavors within the engineering department, you'll ensure adherence to: - Global and local company protocols- Legal mandates- Regulatory stipulations Key duties include: - Developing and maintaining Qualification Master plans for ongoing projects- Managing all aspects of GMP manufacturing system qualification, including Qualification plans, FMEA, DQ, IQ, OQ, PQ- Reviewing and approving technical and GMP-related documentation, such as URS, impact/risk assessments, and qualification documentation- Collaborating with internal and external stakeholders to conduct FAT/SAT and commissioning activities for new manufacturing systems- Coordinating with external suppliers and overseeing their contributions- Addressing Change Controls, CAPAs, and Non-Conformances related to qualification matters
- Bachelor's or Master's degree in Engineering
- Minimum three years of experience in the pharmaceutical industry
- Good knowledge of cGMPs
- Proficiency in English and French
- Knowledge in equipment qualification and automation systems
Based in St-Prex (Vaud)Duration: 6 months This role offers an exciting opportunity to contribute to the advancement and compliance of our operations in a dynamic and evolving environment. If you meet the prerequisites and possess the necessary expertise and passion for ensuring quality standards, we invite you to apply and become a valued member of our dedicated team.