QA CAR-T Qualification Engineer EMEA

NCSL International; Oost-Vlaanderen; Ibrido; EUR 60.000 - 96.000; Tempo pieno

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Descrizione del lavoro

Johnson & Johnson in Ghent, Belgium, is recruiting a QA CAR-T Qualification Engineer for the CAR-T hub in Europe. You will review and approve qualification activities related to Facilities & Utilities and Process Equipment at J&J/Legend Biotech facilities, ensuring compliance and data integrity.

You will collaborate with E&PS and Engineering & Property Service, support regulatory inspections, and act as QA qualification spokesperson to uphold quality standards across the CAR-T program in Europe.

Competenze

• Master's degree in engineering with chemistry or analytical background.
• Knowledge of cGMP and FDA/EU guidance related to manufacturing of cell therapy products.
• Affinity with computerized systems and data management.
• Excellent Dutch and English communication, both written and spoken.
• Strong analytical thinking, risk assessment and communication skills.
• Team-oriented with cross-functional collaboration.

Mansioni

• Review and approve qualification activities for facilities, utilities and process equipment.
• Evaluate deviations and ensure corrective actions are defined and implemented.
• Collaborate with E&PS and Engineering/Property Service on changes.
• Manage data integrity deliverables and calibration records.
• Support regulatory inspections and act as QA qualification spokesperson.
• Participate in system/process improvement and maintain knowledge of regulations.

Conoscenze

Dutch language

English language

Strong communication

Analytical thinking

Risk assessment

Team collaboration

Formazione

Master's degree in engineering (chemistry/analytical)

Strumenti

Computerized systems

Calibration software

Descrizione del lavoro

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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Gent, East Flanders, Belgium, 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

Johnson & J&J Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the CAR-T hub in Europe.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T-cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, J&J is starting up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing J&J Beerse site.

The QA CAR-T Qualification Engineer is part of the CAR-T QA Qualification Team in Ghent. He/She will be responsible for review and approval of qualification and requalification activities, related to Facilities and Utilities (F&U) and Process Equipment at the J&J/Legend Biotech facilities in Ghent.

Job Responsibilities:

• Will work closely together with the E&PS department and guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities & utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to facilities & utilities with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
• Will work closely together with Engineering & Property Service to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
• Will build a strong connect with different quality organizations
• Will manage the compliance status of critical production (make) assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews
• Participates in the preparation for regulatory and customer inspections and act as a spokesperson for QA qualification
• Approves qualification documents (change controls, master documents, protocols, reports, rationales, SOP's, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.
• Participates in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.

Qualifications - External

• master's degree in engineering with chemistry or analytical background or in pharmaceutical sciences
• awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections.
• affinity with computerized systems, System parameter configurations and data management in critical production assets
• ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment
• thorough knowledge of Dutch and English, both orally and in writing
• Strong analytical thinking, risk assessment and communication skills
• Collaboration and teaming skills

Preferred Skills:

Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

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.