QC Equipment Qualification Engineer

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: 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 kledge and understanding of GMP (od 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