Car-T Operations Start-Up Engineer

jj; Zwijnaarde; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

The opportunity to shape a new venture

Competitive remuneration package

Open-ended contract

Résumé du poste

Johnson & Johnson is expanding CAR-T operations in Ghent and building a new production site. You will join the Build Operations team as a Start-Up Engineer to ensure readiness for commercial production and implement new processes and equipment in a regulated GMP environment.

You will collaborate with Ops, QA, QC, MSAT, IT and external partners to drive design, build, and tech transfer activities while upholding integrity and sustainability in all operations.

Qualifications

• Master’s degree in engineering or sciences is required.
• Experience in FPX project management, cell processing, IT systems and advanced manufacturing automation.
• Knowledge of GMP (cGMP, ICH, Eudralex Vol 4, ATMP) is valuable.
• Ability to explore new paths and continuously improve skills.
• Commitment to diversity, equity and inclusion and high integrity.

Responsabilités

• Ensure operational readiness of GMP manufacturing areas for commercial production.
• Support design, build, qualification and tech transfer phases.
• Develop and review documentation for new technologies or equipment.
• Support MES and SAP integration to enable efficiency and compliance.
• Ensure quality, change controls, audits readiness, and regulatory compliance.
• Foster cross-functional collaboration within a multi-project expansion program.

Connaissances

Project management

Cell processing

IT systems

Manufacturing automation

GMP knowledge

Change controls

Diversity inclusion

Formation

Master’s degree (Engineering / Bioscience)

Outils

MES

SAP

Description du poste

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 Manufacturing

Job Sub Function

Manufacturing Pharmaceutical Process Operations

Job Category

Professional

All Job Posting Locations

Zwijnaarde, Belgium

Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Are you inspired to make a meaningful impact on patients' lives?

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

We are currently in the project phase of a new innovative CAR-T project. A growing team of passionate talent is building the new sites in Ghent, developing, and advancing all tools, processes and procedures that ensure a highly reliable, safe, and efficient production process. J&J entered this platform in a global, strategic partnership with Legend Biotech.

As a Start-Up Engineer, you are part of the Build Operations team, where you will be instrumental in ensuring operational readiness for major projects within the Car-T Ghent organization, including facility expansions and the deployment of new equipment or other future-proof advanced technologies in our existing manufacturing areas.

Role and responsibilities

As a key member of our expansion project team, you will collaborate with various other functions in a fast-paced project environment. Your responsibility is to ensure that our GMP manufacturing areas will be operationally ready for commercial production in a timely manner:

• Act as project support to ensure all operational user requirements are captured and effectively implemented throughout the various project phases towards Operations Readiness (Design, Build, Qualification, Tech Transfer)
• Deep dive into the entire manufacturing design process, developing in-depth expertise by supporting the implementation of new processes, optimizing material flows, utilities, and manufacturing systems
• Contribute to the timely development and review of documentation (User Requirement Specifications for new technologies or equipment, Standard Operation Procedure, Work Instructions, Master Batch Records, Qualification Protocols…)
• Support systems and digital integration (MES, SAP, etc.), ensuring systems enable operational efficiency and compliance
• Ensure quality and compliance, including change controls, inspection readiness, and acting as spokesperson during audits
• Drive cross-functional collaboration and stakeholder alignment (Ops, QA, QC, MSAT, EHS, IT, Planning, external partners) within a multi-project expansion program

Experience

Minimum 3 years of relevant experience

Qualification & skills

• Master’s degree, preferably in an engineering or scientific field (Engineering, Bioscience Engineering, Biochemistry, Pharmacy, …)
• Experience in project management (FPX), cell processing, IT systems, advanced manufacturing automation technologies
• Knowledge of the GMP regulatory framework (including cGMP, ICH, Eudralex Vol 4, ATMP, etc.) is considered a valuable asset
• You enjoy exploring new paths, leveraging your knowledge and experience, while continually expanding your skills to discover innovative solutions for emerging challenges.
• You see and seek opportunities, even when they are not immediately obvious.
• You embrace diversity, equity, and inclusion.
• You maintain high standards of integrity, respect, and sustainability.
• You can deal with procedures and guidelines that require strict application, and with changing situations where not everything is clear yet.

Our Offer

• The opportunity to participate in a progressive treatment that gives hope to patients in need
• The ability to help shape a new venture from the start
• An innovative and dynamic working environment
• Opportunities to continue developing and growing within a strong and expanding organization
• An open-ended contract with a competitive remuneration package

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here’s what you can expect

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.

• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

Preferred Skills

• Agile Manufacturing
• Analytics Dashboards
• Business Behavior
• Chemistry
• Manufacturing, and Control (CMC)
• Communication
• Competitive Landscape Analysis
• Data Compilation
• Data Savvy
• Gap Analysis
• Good Manufacturing Practices (GMP)
• Industry Analysis
• Mentorship
• Operational Excellence
• Plant Operations
• Problem Solving
• Process Optimization
• Project Administration
• Technical Credibility

The anticipated base pay range for this position is

€60.000,00 - €96.255,00

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.
• 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.