Continued Process Verification Engineer

Description

Johnson & Johnson is currently seeking a Continued Process Verification Engineer to join our CAR-T team located in Gent, Belgium.

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/.

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. Patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize (CAR) T-cell therapy. This partnership is designed to combine the strengths and expertise of two companies to deliver on the promise of a CAR T platform for immunotherapy and investigational treatment.

To support the CAR-T program in EMEA, we are working with great enthusiasm on expanding our capacity. The CPV engineer is part of the MSAT team and closely connected to the Tech Transfer workstream.

Key responsibilities

• Monitor and Ensure Quality: Take the lead in monitoring the manufacturing process to ensure adherence to Process Validation and Continued Process Verification requirements, playing a critical role in maintaining our high standards of safety and efficacy.
• Data Analysis Expertise: Dive deep into reviewing raw data and statistical analyses, identifying out-of-trend occurrences and specifications, thus safeguarding the integrity of our processes.
• Protocol Leadership: Take the lead in writing, reviewing, and approving CPV protocols and reports, ensuring that our processes are well-documented and legally compliant.
• Technical Leadership: Provide essential technical insights by effectively collaborating with IT business system owners, driving innovations that optimize our operations.
• Proactive Improvement Initiatives: Actively seek out and propose process enhancements and optimization opportunities that drive efficiency and effectiveness in our manufacturing processes.
• Batch Documentation Strategy: Strategically prepare and refine our batch documentation procedures, ensuring they meet evolving regulatory requirements and industry best practice

Qualifications

What You Bring:

• Relevant Experience: While prior experience in a similar role is preferred, we value passion and drive above all.
• Educational Background: A Master’s degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry, etc.) sets a strong foundation for your success in this role.
• Innovative Mindset: A start-up mentality that embraces challenges and proactively seeks solutions will help you thrive in our fast-paced environment.
• Dynamic Leadership: As a change agent, you champion flexibility, creativity, and accountability while expertly navigating strict procedures and guidelines.
• Effective Communication Skills: Your exceptional verbal and written communication skills will empower you to influence others and foster collaboration across diverse teams.
• Commitment to Diversity: You value diversity, equity, and inclusion, and understand its essential role in fostering a thriving work environment.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.