Qualification Specialist - Thermal (m/w/d)

Key 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 Lonza’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 Lonza’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 Lonza 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 Lonza standards.
• Authoring and reviewing Commissioning and Qualification Summary Report and supervising its approval workflow.
  

Qualifications & Requirements:

• Education: Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Physics, or a related field.
• Experience: 3+ years in thermal qualification, validation, or testing within industries like pharmaceutical, biotech, aerospace, automotive, or packaging.
• Technical Skills:
  • Experience with thermal analysis tools (e.g., Ansys, COMSOL, MATLAB).
  • Proficiency in data acquisition systems and environmental testing equipment.
  • Knowledge of thermal dynamics, heat transfer, and insulation materials.
• Certifications (Preferred): ISTA Certification, Six Sigma, Lean Manufacturing, or related credentials.
• Strong problem-solving, documentation, and analytical skills.
• Ability to work in a cross-functional environment and manage multiple projects