Qualification Engineer
MSD
full-time
Posted on:
Location Type: Office
Location: Haarlem • 🇳🇱 Netherlands
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Assembly
About the role
- Provide critical advice and leadership on qualification for new and existing device assembly and corresponding packaging equipment.
- Lead seamless preparation, execution, and optimization of Validation Master Plans, Quality Assurance Plans, Commissioning & Qualification activities, and support equipment change control.
- Execute review assessments to ensure the qualified state for existing packaging and device assembly equipment.
- Function as an independent contributor while supporting global initiatives and site-specific projects and activities that are in scope of the Packaging Technical Operations team.
- Collaborate on validation strategies for MDCPs following regulatory guidelines.
Requirements
- BS degree or higher in Engineering or related field; preferred in Mechanical, Chemical, Biomedical, or Materials Engineering.
- Minimum 5 years’ experience in commissioning and qualification of GMP processes in the pharmaceutical industry.
- Experience with GAMP 5 qualification model and/or V-model, lifecycle approach for system validation including the major milestones of planning, specification for testing, release and maintenance of qualified state.
- Proven commissioning and qualification leadership in life-science industry with GAMP qualification model and subsequent steps such as, GAMP Categories, Lifecycle approach, Risk Based Approach.
- Knowledge of deviation management, change control, validation, and equipment qualification.
- Experience implementing robust control strategies for manufacturing
- Proficient in project management, GMP & MDCP regulations, generating and maintenance of lifecycle documentation.
Benefits
- Competitive salary and a 3% year-end bonus.
- 35,5 days of leave;
- Attractive collective health care insurance package with considerable reduction rates.
- Solid Pension Plan;
- Incentive Plan;
- Travel allowance for commuting;
- On-site sports facilities
- Numerous training, coaching and e-learning modules for long term job opportunities and development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
commissioningqualificationGMP processesGAMP 5 qualification modelV-modellifecycle approachdeviation managementchange controlvalidationequipment qualification
Soft skills
leadershipcollaborationindependent contributorproject management
Certifications
BS degree in EngineeringMechanical EngineeringChemical EngineeringBiomedical EngineeringMaterials Engineering