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Commissioning & Qualification Engineer

Manpower

 
St-Prex
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15/03/2024 100% Temporary (short-term)
Manpower
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.
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.

Contact

Loïc Champlong


About the company

2,8 (32 reviews)

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