summary.

Bern, Bern
Temporary

specialism
engineering
contact
Luca Furler
reference number
20274

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job details

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

For our client, an international company based in Bern, we are seeking a highly skilled Commissioning and Qualification Engineer for a 6-month contract.

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

Luca Furler

+41 58 201 55 50
Basel Professionals IT & Life Sciences

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Commissioning and Qualification Engineer.

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Luca Furler

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