Qualifizierungsexperte Für Verpackungsanlagen (m/w/d)

Merck Merck · Pharma · Vienna, Austria

Merck is seeking a Qualification Expert for Packaging Equipment (m/f/d) at their Vienna, Austria site. This role focuses on the planning, preparation, and execution of qualifications and re-qualifications for packaging lines and related equipment within a biopharmaceutical manufacturing environment. The position requires strong knowledge of GMP, packaging technology, and regulatory guidelines, with responsibilities including documentation, testing, auditing, and project participation.

What you'd actually do

  1. Planning, preparation and execution of qualifications and re-qualifications of plants, equipment and rooms (creation of documents, organization of meetings, creation of schedules) for very complex, product-specific devices and plants with a special focus on packaging lines and devices for in-process control of packaging.
  2. Review and approval of all documents relevant to qualification from suppliers
  3. Review of User Requirement Specifications with a special focus on packaging lines and devices for in-process control of packaging.
  4. Definition of calibration points/ranges for devices
  5. Support for FAT and SAT (Factory Acceptance Test; Site Acceptance Test)

Skills

Required

  • Technical or scientific education (HTL or university degree)
  • Knowledge of packaging machinery and the business field of packaging technology and packaging automation
  • Experience with automated packaging lines (primary/secondary/tertiary packaging)
  • Several years of professional experience in the field of qualification of packaging lines
  • Demonstrable knowledge of GMP requirements in the pharmaceutical sector
  • Problem-solving and root cause analysis skills
  • Project management skills
  • Fluent German and English skills

Nice to have

  • Knowledge of regulatory guidelines, including FDA and EMEA

What the JD emphasized

  • packaging lines
  • devices for in-process control of packaging
  • GMP requirements
  • FDA and EMEA regulatory guidelines