Senior Qualification Engineer

Johnson Johnson; Leiden; On-site; EUR 54,000 - 85,000; Full time

Job summary

Johnson & Johnson Innovative Medicines Biologics Leiden is recruiting a Senior Qualification Engineer to lead validation and qualification for critical manufacturing systems and equipment. You will plan, oversee, and troubleshoot commissioning, qualification, and validation activities while mentoring junior staff.

The role emphasizes regulatory alignment with ICH/EMA/CFR, cGMP inspections, and continuous improvement within a high-performance manufacturing site in Leiden.

Qualifications

• Minimum 4 years of proven experience in the (bio)pharmaceutical industry or related academic experience.
• 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).

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 IQ, OQ, and PQ protocols in collaboration with cross-functional teams.
• Conduct risk assessments related to commissioning and qualification activities.
• Generate and maintain documentation including test scripts, reports, and validation protocols.
• Collaborate with engineering, quality assurance, and production teams to ensure integration of new systems and modifications.
• Coach junior qualification engineers and provide training on validated systems.

Skills

English

CQV experience

Project management

Regulatory knowledge

Quality Assurance

Education

Bachelor's degree in Engineering

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 Innovative Medicines Biologics B.V., a member of the Johnson & Johnson's Family of Companies is recruiting a 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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

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.

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.

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.

Qualifications

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.

What we offer

Johnson & Johnson Innovative Medicines Biologics in Leiden, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Advance Therapeutic Medicinal Products. At Johnson & Johnson Innovative Medicines 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.

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.

Johnson & Johnson is an Affirative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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

The anticipated base pay range for this position is

€53,500.00 - €85,445.00

Benefits

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, 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.