HVAC/Utilities Qualification & Validation Specialist

Key Responsibilities:

• Subject Master for Utilities and HVAC qualification(Clean and black)
• Collaborating closely with Operations, Engineering and QA department on determining qualification and requalification strategy.
• Authoring qualification documentation to ensure all tests were performed according to guidelines and Lonza’s Standards / SOPs.
• Preparation, review, approval and revision of Qualification plans and reports before and after execution.
• 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.
• Conducting and leading qualification and Walkdown performed with or without support of external service providers.
• Ensuring that test documentation (KNEAT or paper based) 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.
• Participate to Deviation Record Board to assess impact on qualification activities
• 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 Quality Summary Report and supervising its approval workflow.
• Communicating fluently (verbally and by writing) in English and knowledge of German is a great advantage.
• Plan/ organise /supervise routine requalification activities
• Preparation and participation to several audit including Swissmedic one.

Qualifications & Requirements:

• Education: Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Environmental Engineering, or a related field.
• Experience: 3+ years in HVAC qualification, cleanroom validation, or utility system validation in regulated industries.

• Technical Skills:

• Experience with environmental monitoring systems, airflow balancing, and cleanroom HVAC testing.
• Knowledge of GMP regulations, cleanroom classifications, and contamination control strategies.
• Proficiency in data loggers, particle counters, thermal mapping, and airflow simulation software.

• Certifications (Preferred):

• Certified Cleanroom Professional (CCP) or CETA Certification
• ASHRAE, ISO 14644, or USP 797/800 expertise
• Six Sigma or Lean Manufacturing certifications

• Strong analytical, documentation, and problem-solving skills.
• Ability to manage multiple projects in a fast-paced, regulated environment.