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Sr. Qualification Engineer
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Sr. Qualification Engineer W
Description
Janssen 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
The Make Asset Management (MAM) 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
As a Sr. 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.
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.
- Perform 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 and implementing necessary validations.
- 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 4 years of relevant 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.
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.
Johnson & Johnson is an Affirmative 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 .
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization Janssen Biologics (7266)
Job Function Project Engineering
Req ID: W
