Commissioning and Qualification Engineer
vor 1 Monat
For our client, a pharmaceutical company based in Bern, we are seeking a highly skilled Commissioning and Qualification Engineer for a 6-month contract position to support a capital expenditure (CAPEX) project.
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 compliance with applicable regulations and industry standards.
General Information:
- Start date: ASAP (no later than 2.04.2024)
- End date: 6 months
- Workplace: Bern
- Workload: 100%
Key Responsibilities:
Â- Support the overall commissioning and qualification activities for the 6-month project.
- Collaborate with project stakeholders to develop commissioning and qualification plans, protocols, and reports.
- Execute commissioning activities, including system turnover verification, alignment checks, functional testing, and documentation of results.
- Perform qualification activities, including installation and operational qualifications (IQ/OQ).
- Work closely with cross-functional teams to coordinate and integrate commissioning and qualification activities within project timelines.
- Identify and mitigate risks during the commissioning and qualification phase, ensuring compliance with regulatory requirements and safety standards.
- Utilize industry best practices and standard operating procedures to conduct commissioning and qualification activities.
- Collaborate with project team members to ensure documentation is completed accurately and on schedule.
Qualifications and Skills:
Â- Bachelor's or Master's degree in Engineering or a related field.
- Minimum of 5 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.
- Proficient in conducting system turnover verification, functional testing, and documentation of results.
- 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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