Qualification Engineer

Job Description:

Johnson & Johnson Biologics, Leiden, is recruiting for a 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.

As a Qualification Engineer, you will play a crucial role in ensuring the successful implementation and validation of manufacturing systems and equipment. Your primary responsibilities will involve overseeing commissioning and qualification activities and contributing to the continuous improvement of validation processes to ensure compliance with regulatory standards and industry best practices.

The Global Engineering Technology (GET) team is responsible for the introduction and maintains 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!

Key Responsibilities:

• Support the commissioning process for new or upgraded systems, ensuring proper installation and functionality.
• Develop qualification plans based on project 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.
• Oversee work managed engineering partners by reviewing qualification deliverables.
• 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.
• Provide training to relevant personnel on validated systems and associated processes.
• Contribute to continuous improvement initiatives by recommending enhancements to commissioning and qualification processes.

Qualifications:

Education:

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

Experience and Skills:

Required:

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

Hybrid Work