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