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QC Equipment Qualification Engineer – 5902 CBO

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a QC Equipment Qualification Engineer on a 6 months contract based in the Bern area.

 

The ideal candidate should have atleast 5 years of experience in Commissioning and Qualification activities in pharmaceuticals or Biotechnology industry.

 

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.

Main Responsibilities:

 

  • Support the overall equipment qualification activities at production site, 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.

 

Qualifications and Experience:

 

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • 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

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.