QA CAR-T Qualification Engineer EMEA

Johnson Johnson; Oost-Vlaanderen; On-site; EUR 70,000 - 95,000; Full time

Job summary

Johnson & Johnson Innovative Medicines is recruiting a QA CAR-T Qualification Engineer for the Ghent CAR-T hub in Europe. The role involves reviewing qualification activities for facilities, utilities, and equipment, and ensuring deviations are properly investigated and CAPAs defined.

You will collaborate with E&PS, Engineering & Property Service, and other quality groups to safeguard product quality and compliance, while supporting inspections and continuous improvement in a fast-changing

Qualifications

• Knowledge of cGMP and FDA/EU guidance for cell therapy manufacturing.
• Familiar with computerized systems and data management in critical assets.
• Strong communication skills and ability to work across departments.
• Ability to navigate changing environments and regulatory expectations.
• Proficiency in Dutch is preferred.

Responsibilities

• Review and approve qualification and requalification activities for facilities and utilities and process equipment.
• Approve change controls and ensure deviations are investigated with CAPAs.
• Maintain compliance status of critical production assets and calibration records.
• Prepare for regulatory and customer inspections and act as QA spokesperson.
• Approve qualification documents including protocols, reports, and SOPs.
• Participate in system/process improvement projects and stay updated on regulations.

Skills

Quality awareness

cGMP knowledge

Data management

Strong communication

Cross-functional teamwork

Dutch language

Education

Master's degree in engineering with chemistry or analytical background or pharmaceutical sciences

Job description

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:

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 .

A bout 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 & Johnson 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