Continued Process Verification Engineer

at  Johnson Johnson

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

• You will be responsible for monitoring the manufacturing process according to Process Validation and Continued Process Verification requirements
• You will be responsible for reviewing the raw data and statistical analyses, analyze out of trends, out of specs and other process parameters
• Write, review and approval of CPV protocols and reports
• You will provide technical leadership by effectively interfacing and collaborating with IT business system owners
• You will pro-actively identify process improvements and optimizations opportunities
• You will strategically prepare for optimizations in the batch documentation process domain
• You will act as a spokesperson for your area during health care inspections

Experience

• It is preferable to have relevant work experience

QUALIFICATIONS

• You have a Bachelor or Master’s Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …)
• You have a start-up/can-do mindset, and you proactively search for solutions
• You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/guidelines which require strict execution
• You work independently under general direction, having a good sense of prioritization and managing multiple tasks simultaneously
• Your verbal and written communication skills enable you to influence without authority
• You embrace diversity, equity, and inclusion
  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

• You will be responsible for monitoring the manufacturing process according to Process Validation and Continued Process Verification requirements
• You will be responsible for reviewing the raw data and statistical analyses, analyze out of trends, out of specs and other process parameters
• Write, review and approval of CPV protocols and reports
• You will provide technical leadership by effectively interfacing and collaborating with IT business system owners
• You will pro-actively identify process improvements and optimizations opportunities
• You will strategically prepare for optimizations in the batch documentation process domain
• You will act as a spokesperson for your area during health care inspection