Qualification Engineer

Are you passionate about bringing new products to life and ensuring seamless qualification execution and supply to our patients? We're looking for a driven and collaborative Qualification Engineer to join our customer-centric Packaging Technical Operations team in Haarlem. In this role, you will provide critical advice and leadership on qualification for new and existing device assembly and corresponding packaging equipment. Your contribution in the qualification domain supports our mission as a launch site for new products.

The Customer-Centric Packaging Technical Operations team at the Haarlem site is responsible for driving technology transfer of new products into the site, execution of capital projects to design and qualify device assembly and packaging lines aligned with new product needs, supporting the packaging operations, and providing support with the design, development, and improvement of packaging components.

Purpose of the position

To strengthen our team, we are looking for a Qualification Engineer to join our Haarlem Packaging Technical Operations Team. In this role, you will serve as an Equipment Qualification subject matter expert for the team. You will advise and lead the qualification packages for our new projects and re-qualification of existing packaging lines in the GMP area. You will lead seamless preparation, execution, and optimization of Validation Master Plans, Quality Assurance Plans, Commissioning & Qualification activities, and support equipment change control. For existing packaging and device assembly equipment, you will execute review assessments to ensure the qualified state. With your support, the team will deliver projects within agreed scope, schedule, and budget while ensuring traceability and compliance with internal and external policies.

In this role, you will 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. You will be the sparring partner for Project Managers, Project Engineers, and Documentation Writers. You will be the advisor for the MDCP Engineer, Tech Transfer Lead, and Packaging Technical Operations team. As a partner and advisor, you will challenge the status quo to ensure effective commissioning and qualification of new and existing packaging processes. As the Qualification Engineer, you will be involved in the development and execution of technical and risk management documentation, problem-solving, and continuous improvement, working with internal and external partners. This role will work closely with the Haarlem Packaging Operations Team, site Quality, and Operations teams.

Primary Responsibilities

• Lead or advise on planning and execution of commissioning & qualification, change control, and collaborations with stakeholders.
• Facilitate qualification strategy meetings with team and stakeholders to define the commissioning and qualification scope, execution strategy, and project deliverables.
• Participate in local and global activities related to qualification standards, qualification topics, and subsequent activities.
• Support Pre-Approval Inspection activities for programs by proactively contributing to the preparation, execution, and reporting.
• Collaborate on validation strategies for MDCPs following regulatory guidelines.
• Maintain compliance with qualification documentation related to new and existing packaging equipment and device assembly.
• 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 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.
• Preferred: Experience in ISO 13485, ISO 14971, and supporting regulatory inspections. Experience with autoinjectors, prefilled syringes, drug-delivery systems, and related components.

Required Skills:

Adaptability, Capital Project Management, Change Management, Data Analysis, Deviation Management, Equipment Qualification, Facility Management, Global Initiatives, GMP Compliance, Good Manufacturing Practices (GMP), Maintenance Supervision, Occupational Safety and Health, Packaging Processes, Patient Safety, Quality Assurance Systems, Quality Control Management, Quality Management, Regulatory Audits, Regulatory Inspections, Sterile Manufacturing, System Validation, Team Leadership, Troubleshooting, Vaccine Manufacturing, Validation Master Plans

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

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