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Job Function:

Supply Chain Engineering

Job Sub Function:

Project Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Leiden, South Holland, Netherlands

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.
 

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 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.
 

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 advantage.
   

What we offer:

Janssen Biologics in Leiden, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Advance Therapeutic Medicinal Products. At Janssen Biologics, enthusiastic people are working together in a high-performance culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and contribute to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark!

Your development is key to us, and we consider it our day-to-day responsibility. We believe we can make a difference together and take your career seriously. Through on-the-job and development trainings, assignment to projects and programs, we are committed to your personal and professional growth. Via multiple employee benefits, our company offers support for you and your family now and in the future.

The anticipated base pay range for this position is 64,000 EUR to 103,040 EUR on an annual basis and includes 8% holiday pay.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

 

 

Required Skills:

 

 

Preferred Skills: