Senior Qualification Engineer

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 53,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days and parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicines Biologics Biologics in Leiden, Netherlands, is recruiting a Sr. Qualification Engineer to support commissioning and qualification of complex systems for biotherapeutics manufacturing.

The role requires a strong CQV background, knowledge of ICH/EMA/CFR, and collaboration with cross-functional teams to ensure compliant validation activities. Leiden site offers growth within a high-performance culture focused on safety, quality, and innovation.

Qualifications

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

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, identifying and mitigating potential risks.
• Generate and maintain comprehensive documentation, including test scripts, reports, and validation protocols, ensuring regulatory compliance.
• Participate in change control processes, assessing impact of changes on validated systems.
• Collaborate with engineering, quality assurance, and production teams to ensure detailed integration of new systems.
• Identify and resolve issues related to equipment, systems, or processes during 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.

Skills

Communication skills

English proficiency

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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

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.
• 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.
• 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.

Pay

The anticipated base pay range for this position is: €53,500.00 - €85,445.00

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.
• 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.
• 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.

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

Johnson & Johnson is an Affirmitive 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.