In this role, you will oversee qualification and validation activities for equipment, infrastructure, and computerized systems within large-scale aseptic manufacturing projects. You act as the quality interface for all CSV- and automation-related topics, guiding project teams and vendors to ensure compliance from concept through implementation.
Start Date: 05.01.2026
Duration: 12 Months
Place of Work: Stein (AG)
Key Responsibilities
* Ensuring qualification and validation compliance for equipment, infrastructure and computerized systems across aseptic drug product CAPEX projects
* Reviewing and approving SOPs, URS documentation, validation plans, protocols and reports, including CQV and CSV records
* Providing QA oversight, guidance and decision-making on qualification and validation matters for project teams and external vendors
* Acting as the primary QA contact for lifecycle management of qualified systems and for documentation within global platforms such as Kneat, Trackwise and DMS
* Managing quality deviations, change controls and CAPAs, ensuring timely closure and appropriate escalation when needed
Candidate Profile
* Bachelor’s or Master’s degree in Engineering, Life Sciences or a related discipline
* Extensive experience in GMP pharmaceutical environments, ideally within a Quality function
* Background in QA for CSV and automation systems supporting aseptic fill-finish processes
* Knowledge of qualification and validation for equipment such as filling lines, lyophilizers, clean utilities and cleanroom systems
* Fluent English; German language skills are an advantage
Job ID 18464
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