QC Equipment Qualification Engineer

vor 1 Monat

Bern, Bern, Schweiz Randstad Vollzeit

For 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: ASAPEnd date: min. 6 monthsExtension: possible, to be discussedWorkplace: BernWorkload: 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

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