Commissioning and Qualification Engineer

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