Staff Qualification Engineer

Job Description:

Johnson & Johnson Biologics, Leiden, is recruiting for a Staff 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 Staff Qualification Engineer, you will provide guidance and drive standardization in 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.

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 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 driving 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 6 years of proven experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Minimum 4 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 focussed;
• Good communication skills in English (both oral and written);

••Experience with cGMP inspections, process excellence and project management is an advantag

Qualifications:

Education:

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

Experience and Skills:

Required:

• Minimum 6 years of proven experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Minimum 4 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 focussed;
• Good communication skills in English (both oral and written);

••Experience with cGMP inspections, process excellence and project management is an advantage.

Qualifications:

Education:

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

Experience and Skills:

Required:

• Minimum 6 years of proven experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Minimum 4 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 focussed;
• Good communication skills in English (both oral and written);

••Experience with cGMP inspections, process excellence and project management is an advantage

Qualifications:

Education:

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

Experience and Skills:

Required:

• Minimum 6 years of proven experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Minimum 4 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 focussed;
• Good communication skills in English (both oral and written);
• Experience with cGMP inspections, process excellence and project management is an advantage.

Hybrid Work