Senior Engineer MDCP – Packaging Technical Operations

About the Role

Join us in Haarlem as a Senior Engineer MDCP – Packaging Technical Operations. Are you passionate about bringing new products to life, ensuring seamless technical execution and supply to our patients? We're looking for a driven and collaborative Senior Engineer MDCP to join our Packaging Technical Operations team in Haarlem. In this role, you'll be at the heart of our mission as a launch site for new products, leading technical readiness for our new MDCP products with precision and purpose.

Technical Operations at the Haarlem site is responsible for design & technology transfer of new products into the site, component support, and execution of capital projects to install or upgrade device assembly & packaging line capabilities aligned with new product needs.

Purpose of the Position

We are looking for a Senior MDCP Engineer to join our Haarlem Packaging Technical Operations Team. You will be the key contact for medical device and combination product (MDCP) activities, supporting design, tech transfer, and sustainment at the site. This role includes ownership of MDCP related technical documentation to ensure compliance and quality. Ideal candidates have strong experience in design controls, device risk management, process validation, problem solving, and MDCP platforms like prefilled syringes and autoinjectors. You'll thrive in a fast-paced environment, managing priorities effectively while communicating clearly with stakeholders to deliver robust technical solutions. This individual is expected to function as an independent contributor while supporting global or site-specific projects.

The role includes leading, enabling or consulting in the development and execution of technical and risk management documentation associated with MDCP new product introductions, assessing changes to device assembly and packaging processes, problem-solving, and continuous improvement working with internal and external partners.

This role will work closely with the Haarlem site QA and Operations MDCP Leads, Device Development and Technology, PTO Engineers, and our Product Development and Commercialization groups, among others.

Primary Responsibilities

• Facilitate design & technology transfer from development to launch for MDCPs
• Lead or support device risk management for MDCP product introductions or changes, collaborating with stakeholders
• Apply design control expertise to create value-added solutions for medical devices and combination products
• Lead technical investigations for commercial MDCP products
• Collaborate on validation strategies for MDCPs following regulatory guidelines
• Maintain compliance of technical documentation related to MDCPs and support regulatory filings and inspections
• Demonstrate inclusive communication, solicit stakeholder feedback, and ensure decisions prioritize patient safety and customer needs
• Ensure all activities comply with company safety, quality, and regulatory procedures

Your Profile

Required

• BS degree or higher in Engineering or related field; preferred in Mechanical, Chemical, Biomedical, or Materials Engineering
• Minimum 5 years' experience in medical device and combination product manufacturing, assembly, and packaging
• Proven technical leadership in medical device/combination product commercialization and operations support
• Experience with autoinjectors, prefilled syringes, drug-delivery systems, and related components
• Knowledge of deviation management, change control, process scale-up, validation, and equipment qualification
• Experience implementing robust control strategies for MDCP manufacturing including device assembly and packaging operations
• Proficient in project management, MDCP regulations, and generating design controls lifecycle documentation

Preferred

• Experience in ISO 13485, ISO 14971, and supporting regulatory inspections

Required Skills

• Change Management
• Collaborative Development
• Data Analysis
• Deviation Management
• Equipment Qualification
• Facility Management
• Good Manufacturing Practices (GMP)
• Manufacturing
• Medical Devices
• Packaging Processes
• Project Management
• Regulatory Inspections
• Team Leadership
• Technology Transfer
• Troubleshooting
• Vaccine Manufacturing

Preferred Skills

• Current Employees apply HERE
• Current Contingent Workers apply HERE

What We Offer

• 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

How to Apply

For questions about this vacancy, please send an email including the vacancy number and job title to: RecruitmentNL@MSD.com

Additional Information

Employee Status: Regular

Relocation: VISA Sponsorship

Travel Requirements: Flexible Work Arrangements: Not Applicable

Shift: Valid Driving License

Hazardous Material(s): Job Posting End Date: 03/31/2026

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Search Firm Representatives

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

About Our Company

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.