JobdescriptionFor our client, an international company based in Bern, we are seeking a highly skilled Equipment Qualification Engineer for a 6-month contract position to support capital expenditure (CAPEX) projects.
As an Equipment Qualification Engineer, you will play a crucial role in ensuring the successful qualification of Quality Control (QC) equipment in compliance with applicable regulations and industry standards.
General Information:
- Start date: ASAP
- End date: min. 6 months
- Extension: possible, to be discussed
- Workplace: Bern
- Workload: 100%
Key Responsibilities:
- Support the overall equipment qualification activities focusing on QC equipment.
- Collaborate with project stakeholders to develop qualification plans, protocols, and reports for QC equipment.
- Execute qualification activities, including installation and operational qualifications (IQ/OQ) for QC equipment.
- Conduct system turnover verification, functional testing, and documentation of results for QC equipment.
- Work closely with cross-functional teams to coordinate and integrate equipment qualification activities within project timelines.
- Identify and mitigate risks during the qualification phase, ensuring compliance with regulatory requirements and safety standards.
- Utilize industry best practices and standard operating procedures to conduct equipment qualification activities.
- Collaborate with project team members to ensure accurate and timely completion of documentation for equipment qualification.
Your Profile:
- 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 minimum of 6-month contract duration.
- Business fluency in English, German language is a plus
Luca Furler