Our client is seeking a skilled Thermal Validation Subject Matter Expert to join their BIO Biologics Division Services (BDS) team for a 9-month contract in Visp. The successful candidate will be responsible for ensuring the qualification and validation of process and support equipment, including autoclaves, SIP, fridges, and freezers, in a GMP-compliant environment.
The candidate will collaborate closely with cross-functional teams in Operations, Engineering, and QA departments to manage qualification documentation and ensure compliance with Client's standards and SOPs. They will be involved in risk analysis, testing, deviation management, and CAPA resolution to maintain the highest standards of product quality and regulatory compliance.
Responsibilities:
- Working under GMP Bio-technology company environment following hygiene and gowning procedures
- Subject Master Expert of thermal validation for Process and Support equipment (incl. autoclaves, SIP, fridges / freezers…)
- Collaborating closely with Operations, Engineering and QA department
- Authoring and/or Approving qualification document from CAPEX to ensure all tests were performed according to guidelines and Client's Standards / SOPs
- Preparation, review, approval and revision of Qualification plans and reports
- Ensuring that the test scope and test execution meet the requirements of Client's Standards / SOPs
- Ensuring that DQ (URS, GMP-RA, uCQP…) document are in accordance with Operations department requirements
- Revising GMP risk analyses after OQ to prepare PQ
- Conducting and leading qualification testing performed with support of external service providers
- Ensuring that test documentation (paper based or KNEAT)is properly filed in a CQ dossier
- Assuring that change control of documentation and equipment complies with client standards
- Authoring DR, CAPA and Investigation in Trackwise to participate to Deviation Record Board
- Managing the resolution of test deviations, CAPA and TCR
- Ensuring that test results and deviations are recorded accurately and are conform with Client standards
- Authoring and reviewing Commissioning and Qualification Summary Report and supervising its approval workflow
Qualifications:
- Proven experience in thermal validation within a GMP-compliant bio-technology environment.
- Expertise in validating equipment such as autoclaves, SIP, fridges/freezers.
- Strong knowledge of GMP standards, SOPs, and qualification documentation processes.
- Ability to work collaboratively with cross-functional teams.
- Experience with KNEAT or similar systems for managing test documentation.
- Strong problem-solving skills for managing deviations, CAPA, and testing challenges.
- Fluent in English (required); knowledge of German is an advantage
For further information about this position, please apply with your CV
*Please note, only those with the right to work in Switzerland can apply!
