Quality Engineering Specialist

vor 2 Monaten

Stein, Schweiz EPM Scientific - Phaidon International Vollzeit

We are seeking a QA Specialist, CSV & Automation.

The ideal candidate will be responsible for overseeing the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, utilities, and GMP manufacturing as part of Lonza's CAPEX project portfolio in Stein, AG.

Key Responsibilities:

  1. Oversee the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, utilities, and GMP manufacturing.
  2. Manage the commissioning and qualification of large CAPEX projects from ideation to execution, ensuring adherence to Lonza Quality policies.
  3. Approve SOPs, qualification/validation protocols, and project-related documents (e.g., URS, FAT/SAT).
  4. Provide QA leadership and support on qualification/validation topics, ensuring vendors are appropriately qualified.
  5. Serve as the primary contact for lifecycle and compliance issues related to equipment and systems qualification/validation, managing documentation in global systems (e.g., Kneat, Trackwise, DMS, Unifier).
  6. Handle quality deviations, changes, and CAPAs/tasks, leading their resolution and escalating when necessary.

Key Requirements:

  1. Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  2. Significant experience in the GMP-regulated pharmaceutical industry, ideally within a Quality Unit.
  3. Proven experience in QA for CSV/Automation of GMP systems related to aseptic fill-finish processes and facilities.
  4. Fluent in English; proficiency in German is a plus.

*Please note, only those with the right to work in Switzerland can apply

#J-18808-Ljbffr

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