Car-T Operations Start-Up Engineer

7555-Janssen Pharmaceutica NV Legal Entity; Zwijnaarde; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being programs

Résumé du poste

Johnson & Johnson in Belgium is seeking a Start-Up Engineer for the Build Operations team in Ghent. You will ensure operational readiness for major CAR‑T projects, including facility expansions and deployment of new equipment to support commercial production.

You will collaborate across Ops, QA, QC, MSAT, IT and external partners to drive process optimization, documentation development, and systems integration within an expanding manufacturing environment.

Qualifications

• Master’s degree in engineering or a scientific field.
• Experience in project management, FPX, cell processing, IT systems, and advanced manufacturing automation technologies.
• Knowledge of GMP regulatory framework (cGMP, ICH, Eudralex Vol 4, ATMP).
• You embrace diversity, inclusion, integrity, and sustainability in procedures and changing situations.

Responsabilités

• Act as a key member of the expansion project team in a fast-paced environment.
• Ensure GMP areas are operationally ready for commercial production across project phases (Design, Build, Qualification, Tech Transfer).
• Deep dive into manufacturing design and support implementation of new processes and systems.
• Develop and review documentation (User Requirements, SOPs, Work Instructions, Master Batch Records, Protocols).
• Support MES, SAP, and other systems to enable efficiency and compliance.
• Engage in audits and drive cross-functional collaboration across Ops, QA, QC, MSAT, IT and external partners.

Connaissances

GMP knowledge

Project management

Technical credibility

Formation

Master’s degree in Engineering or related field

Outils

MES

SAP

Description du poste

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 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.

All Job Posting Locations: Zwijnaarde, Belgium

Job Function: Supply Chain Manufacturing. Job Sub Function: Manufacturing Pharmaceutical Process Operations. Job Category: Professional.

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.

The anticipated base pay range for this position is: €60.000,00 - €96.255,00

Benefits:

In addition to base pay, we offer the following 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.

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Required 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

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