CQV Thermal Validation Specialist

Requirements:

• Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others. T
• Validation documentation deliverables, URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
• Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
• Writing reports of completed validation activities. Work to identify efficiencies in the validation program approach.
• Working to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
• Performing assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s.
• Writing and/or revising procedures applicable to the Engineering activities.
• Supporting the Engineering group to prepare the validation, requalification, and maintenance program. Perform other duties as assigned.

• Collaborating closely with stakeholders, including Operations, Engineering, Quality Assurance departments, and service providers.

• Authoring and/or approving qualification documents in both CAPEX and OPEX phases to ensure all activities comply with guidelines.

• Preparing, reviewing, approving, and revising qualification plans and reports.

• Conducting and leading qualification testing in collaboration with external service providers.

• Ensuring proper filing of test documentation (paper-based or via KNEAT system) in the CQV dossier.

• Ensuring that change control for documentation and equipment complies with company’s standards.

• Creating Deviations (DR), Corrective and Preventive Actions (CAPA), and Investigations in TrackWise, and participating in Deviation Record Board (DRB) meetings.

• Managing and supporting the resolution of test deviations, CAPAs, and Technical Change Requests (TCRs).

• Authoring and reviewing the Commissioning and Qualification Summary Report and overseeing the approval workflow.

• Participating in On-the-Job Trainings (OJT) to be qualified to perform SME-level qualification activities.

• Delivering training for the Cornerstone curriculum and maintaining up-to-date training status.

• Responsible for the commissioning and qualification of new equipment, requalification, decommissioning of existing equipment, and execution of periodic reviews as defined.

• Supporting maintenance activities, process improvements, and optimization of equipment under the CQV specialist’s responsibility.

• Participating in audits conducted by regulatory authorities, customers, and internal groups.

Requirements:

• Education Required: Min. Bachelor’s Degree in Science or Technical field.
• Fluent German and English
• Min. 5 years of experience in pharma industry.

• Proven experience in:

  • CQV activities (IQ, OQ, PQ)

  • Thermal validation (e.g. autoclaves, SIP, fridges, freezers)

  • Working with external service providers

  • Deviation/CAPA management using systems like TrackWise

  • Handling risk analyses (e.g. GMP-RA)

  • GMP / GxP regulations (EU GMP, FDA CFR 21 Part 11, ICH Q9/Q10)

  • Validation lifecycle and V-model approach

  • Change control and deviation systems

  • Design Qualification (DQ), User Requirement Specifications (URS), GMP Risk Assessments