Junior QA Specialist, CSV

vor 8 Stunden

Stein, Aargau, Schweiz Adryan Vollzeit

Junior QA Specialist, CSV & Automation

Location: Stein

Duration: 12 months

We are seeking an experienced
QA Specialist, CSV & Automation
to support large-scale CAPEX projects at a sterile drug product manufacturing site in Switzerland. This role focuses on ensuring GMP compliance for equipment, utilities, facilities, and computerized systems supporting aseptic manufacturing operations.

The successful candidate will provide quality oversight across the full project lifecycle, from early design through execution, commissioning, and qualification. Responsibilities include establishing and approving qualification and validation strategies, reviewing and approving CQV/CSV documentation (such as URS, FAT/SAT, protocols, and reports), and ensuring alignment with internal quality systems and regulatory expectations. The role acts as a key quality point of contact for equipment and computerized systems lifecycle management and supports the effective use of global quality systems and tools.

The position also involves managing quality events such as deviations, changes, and CAPAs, providing leadership in their timely resolution, and offering guidance to project teams and vendors on qualification and validation best practices.

Key Requirements:

  • Degree in Engineering, Life Sciences, or a related discipline
  • Strong experience in the GMP-regulated pharmaceutical industry, ideally within a Quality function
  • Proven QA experience supporting CSV and automation for aseptic fill-finish facilities, including filling lines, lyophilization, clean utilities, and cleanroom systems
  • Fluency in English; German language skills are an advantage

This role offers the opportunity to contribute to high-impact sterile manufacturing projects within a regulated and technically advanced environment.

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