Qualification Engineer

Merck Sharp & Dohme Corp

Haarlem, Netherlands
Competitive salary; 3% year-end bonus; 35.5 days o...
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Gmp process commissioning and qualification
Validation master plan development
Gamp 5 qualification model expertise
** Merck Sharp & Dohme Corp is seeking a Qualification Engineer to join their Packaging Technical Operations team in Haarlem, Netherlands. The role involves leading and advising on the qualification of device assembly and packaging equipment, ensuring compliance with regulatory standards and supporting new product launches. **

Job Summary

  • This role serves as an Equipment Qualification subject matter expert responsible for leading the preparation, execution, and optimization of Validation Master Plans and Commissioning & Qualification activities.
  • The team supports the mission as a launch site for new products by driving technology transfer and ensuring seamless qualification of device assembly and packaging lines aligned with patient needs.
  • Candidates will receive competitive benefits including a 3% year-end bonus, 35.5 days of leave, and access to on-site sports facilities and training modules.

Matching Summary

Match Score: 75

** Merck Sharp & Dohme Corp is seeking a Qualification Engineer to join their Packaging Technical Operations team in Haarlem, Netherlands. The role involves leading and advising on the qualification of device assembly and packaging equipment, ensuring compliance with regulatory standards and supporting new product launches. **

Salary

Competitive salary; 3% year-end bonus; 35.5 days of leave; collective health care insurance; Pension Plan; Incentive Plan

Skills & Requirements

Must-have

  • GMP process commissioning and qualification
  • Validation Master Plan development
  • GAMP 5 qualification model expertise
  • Change control and deviation management
  • Risk-based approach implementation

Nice-to-have

  • ISO 13485 and ISO 14971 experience
  • Autoinjector and prefilled syringe knowledge
  • Drug-delivery system familiarity
  • Inclusive communication skills
  • Global initiative collaboration

Key Requirements

  • BS degree in Engineering or related field
  • Minimum 5 years in GMP commissioning and qualification
  • Experience with lifecycle validation models (GAMP 5/V-model)

Work Rights

Not specified

Tailored Resume

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