We are looking for a CQV Thermal Mapping Consultant to join our teams in Visp and provide subject matter expertise in thermal validation activities for process and support equipment.
Your Responsibilities
Act as Subject Matter Expert (SME) in thermal validation for equipment such as autoclaves, SIP systems, refrigerators, and freezers.
Lead qualification activities, including commissioning, qualification, requalification, decommissioning, and periodic reviews.
Execute and oversee qualification testing, collaborating with external service providers and internal stakeholders (Operations, Engineering, QA).
Prepare, review, and approve qualification plans, protocols, and reports across CAPEX and OPEX phases, ensuring compliance with guidelines and SOPs.
Ensure DQ documentation (URS, GMP risk assessments, uCQP) reflects operational requirements and update GMP risk analyses after OQ for PQ readiness.
Manage documentation in paper-based or electronic systems (e.g., KNEAT), ensuring traceability and proper filing within CQ dossiers.
Lead resolution of deviations, CAPAs, and technical changes through Trackwise, and participate in deviation review meetings.
Provide technical input during audits from regulatory authorities, customers, and internal quality teams.
Deliver training on cornerstone curriculum topics, perform OJTs, and maintain compliance with training requirements.
Support continuous improvement, maintenance activities, and equipment optimization initiatives.
Your Profile
Bachelor's degree in Science or a technical discipline.
Proven expertise in thermal validation processes and equipment.
Hands-on experience with Ellab software solutions (ValSuite, eVal Pro), data loggers, and thermocouples.
Strong technical writing skills with experience authoring validation deliverables.
Detail-oriented with strong problem-solving and risk assessment capabilities.
Skilled in managing change control processes and ensuring compliance.
Excellent communication skills with ability to collaborate across teams and with service providers.
Flexible, proactive, and adaptable to evolving project needs.
Fluency in English is required, German is a plus.