MDCP Engineer: Autoinjectors, Automation & Process Validation

MSD Malaysia; Haarlem; On-site; EUR 70,000 - 105,000; Full time

Benefits offered by this job

Competitive salary

35.5 vacation days per year

8% holiday allowance and 3% year-end

Excellent pension plan

On-site restaurant

Gym or sports subscription allowance

Lyra Health well-being support

Prayer and meditation room

Job summary

MSD Haarlem seeks an MDCP Engineer to drive medical device and combination product development, technology transfer, and lifecycle management. You will apply design controls, risk management, and process validation to enable scalable, compliant manufacturing.

Collaboration across Quality, Regulatory, Manufacturing, and Product Development is essential to our global portfolio. The role emphasizes problem solving, cross-functional teamwork, and effective communication with diverse stakeholders.

Qualifications

• BS degree or higher in Engineering (Mechanical, Biomedical, Chemical, Materials, or similar).
• 3+ years of experience in medical devices or combination products (e.g., autoinjectors, pre‑filled syringes, MDCPs).
• Experience with manufacturing equipment, automation, DFM, and qualification activities (IQ/OQ/PQ).
• Knowledge of root cause analysis, structured problem-solving, and process improvement.
• Experience with design transfer, tech transfer, process validation, and scale‑up.
• Strong understanding of risk management (FMEA, hazard analysis, control strategies).
• Experience with change control, deviation management, and QMS documentation.
• Cross‑functional project management experience in international environments.
• Excellent communication skills in English; Dutch is a plus.
• Preferred: 5+ years in medical device/pharma/biotech, with experience in design control, verification testing, TMV, metrology, and automated assembly/manufacturing support.

Responsibilities

• Facilitate technology and design transfer of medical devices and combination products from development through commercialization.
• Contribute to the design, build, and validation of semi‑automated and fully automated autoinjector assembly systems and combination product kit assembly lines.
• Own the technical aspects of investigations related to the qualification and commercial operation of MDCP assembly systems.
• Support root cause analyses, CAPA activities, deviation investigations, and troubleshooting efforts.
• Utilize device risk management tools (d/pFMEA, QRA, OER, etc.) to support the development and maintenance of device and combination product risk management files.
• Demonstrate strong communication skills by integrating input from multiple stakeholders and effectively communicating decisions to key stakeholders and sponsors.
• Actively seek feedback to ensure customer and stakeholder needs remain central to decision‑making and expectations.

Education

BS degree or higher in Engineering (Mechanical, Biomedical, Chemical, Materials, or similar)

Job description

MSD Haarlem seeks an MDCP Engineer to drive medical device and combination product development, technology transfer, and lifecycle management. You will apply design controls, risk management, and process validation to enable scalable, compliant manufacturing.

Collaboration across Quality, Regulatory, Manufacturing, and Product Development is essential to our global portfolio. The role emphasizes problem solving, cross-functional teamwork, and effective communication with diverse stakeholders.