Senior Qualification Engineer

Job Description:

Johnson & Johnson Innovative Medicines Biologics B.V., a member of the Johnson & Johnson's Family of Companies is recruiting a fixed term (1 year) Sr. Qualification Engineer to be based in Leiden, Netherlands. Our site produces biotherapeutic drug substance and is growing our portfolio to include novel advance therapeutic medicinal products.

The Global Engineering Technology (GET) team is responsible for the introduction and maintenance of assets on the site. Within this organization, the C&Q team contributes by performing commissioning and qualification activities for GMP equipment, utilities and facilities. To build up and strengthen our team, we are looking for hardworking and dedicated people. This is the best moment to join us. Apply today for this exciting opening!

As a Senior Qualification Engineer, you will lead the validation and qualification efforts for critical manufacturing systems and equipment, ensuring that processes align with stringent regulatory standards and industry best practices. Your role will include planning, oversight, and troubleshooting of commissioning, qualification, and validation activities, with a focus on enhancing processes and providing mentorship to junior team members.

Please be aware that this opportunity is offered as a fixed-term position.

Key Responsibilities:

• Support the commissioning process for new or upgraded systems, ensuring proper installation and functionality.
• Develop qualification plans for highly complex projects based on user requirements, regulatory guidelines, and company standards.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in collaboration with cross-functional teams.
• Conduct risk assessments related to the commissioning and qualification activities, identifying and mitigating potential risks.
• Generate and maintain comprehensive documentation, including test scripts, reports, and validation protocols, ensuring compliance with regulatory requirements.
• Participate in change control processes, assessing the impact of changes on validated systems.
• Collaborate with engineering, quality assurance, and production teams to ensure detailed integration of new systems and modifications.
• Identify and resolve issues related to equipment, systems, or processes during the commissioning and qualification phases.
• Foster skill development within the team by coaching junior qualification engineers
• Provide training to relevant personnel on validated systems and associated processes.
• Contribute to continuous improvement initiatives by recommending enhancements to commissioning and qualification processes.

Education:

• Bachelor’s degree or equivalent degree in Engineering (Chemical, Mechanical, or Industrial) or other scientific field is required.

Experience and Skills:

Required:

• Minimum 4 years of proven experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Minimum 2 years of proven experience working in a commissioning, qualification, validation (CQV) role.
• Familiar with regulations (ICH, EMA, CFR) and industry standard (ISPE, PDA)
• Accurate, structured, flexible and customer focused;
• Good communication skills in English (both oral and written);
• Experience with cGMP inspections, process excellence and project management is an advantage.

Preferred:

• Proven experience in facility and utility qualification is preferred.

Preferred Skills:

Analytical Reasoning, Budgeting, Collaboration, Communication, Consulting, Customer Centricity, Feasibility Studies, Issue Escalation, Lean Supply Chain Management, Organizational Project Management, Product Reliability, Project Engineering, Quality Assurance (QA), Science, Technology, Engineering, and Math (STEM) Application, Scientific Research, Technologically Savvy

Hybrid work