Commissioning and Qualification Engineer
Jobdescription
For our client, an international company based in Bern, we are seeking a highly skilled Commissioning and Qualification Engineer for a 6-month contract.
As a Commissioning and Qualification Engineer, you will play a crucial role in ensuring the successful commissioning and qualification of facilities, systems, and equipment in manufacturing production and QC in compliance with applicable regulations and industry standards.
General Information :
- Start date : ASAP
- End date : 31.12.2024
- Extension : possible
- Workplace : Bern
- Workload : 100%
Key Responsibilities :
The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that :
re-) qualification of production / QC equipment is performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Write / review Commissioning & Qualification plans and reports.
- Execution of RQ, IQ, OQ including protocol deviations, investigation, and corrective action activities
- Plan and track execution of commissioning & qualification activities / documentation versus project(s) timelines.
- Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact / risk assessment, Master plans, qualification documentation)
- Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners
- Coordination and oversight of external suppliers
Your Profile :
- Bachelor’s or Master’s degree in Engineering or a related field.
- Minimum of 3 years of experience in commissioning and qualification activities in in pharmaceuticals or biotechnology industry.
- Strong knowledge and understanding of GMP (Good Manufacturing Practice) guidelines and regulatory requirements.
- Experience in developing and executing commissioning and qualification plans, protocols, and methodologies.
- Familiarity with qualification activities such as IQ / OQ.
- Excellent problem-solving and analytical skills, with the ability to identify and resolve issues proactively.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented, with exceptional organizational skills and the ability to manage multiple tasks and priorities simultaneously.
- Availability to commit to a 6-month contract duration.
- Business fluency in English, German language is a plus
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