QC Equipment Qualification Engineer
Duration: 03/06/2024 to 31/12/2024 (6-month Contract)
Start: No later than June 3rd
Location: Bern, Switzerland
Overview: 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.
Responsibilities:
- Support 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.
Requirements:
- Bachelor's or Master's degree in Engineering or a related field.
- Minimum of 5 years of experience in commissioning and qualification activities in the pharmaceutical 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.
- Availability to commit to a minimum of a 6-month contract duration.
- Availability to start this role by June 3 rd 2024
- Business fluency in English; German language skills are a plus.
If you're ready to contribute to cutting-edge projects in the pharmaceutical industry, apply now to join the team in Bern, Switzerland!