Job Description

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