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Engineering
Manufacturing Engineering
Facility & Equipment
General
Manufacturing
Quality
Quality
Quality Control
Quality Assurance
Compliance
Quality Systems
Validation
Staff
Procurement & Supply Chain
About the vacancy
Engineering
Manufacturing Engineering
Facility & Equipment
General
Manufacturing
Quality
Quality
Quality Control
Quality Assurance
Compliance
Quality Systems
Validation
Staff
Procurement & Supply Chain
ExpertMaster’s Degree (WO)PermanentFull time Gent, Belgium
About Your Next Job Job Description:
& Johnson Innovative Medicines is recruiting a CAR-T QA C&Q Lead 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 started up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operated from the existing J&J Beerse site.
As the CAR-T Qualification lead, you will play a pivotal role in ensuring the qualification of critical systems, equipment, facilities and utilities used in CAR-T Manufacturing. You will lead a team of QA C&Q engineers and collaborate cross functionally with engineering, maintenance, validation, and operation teams to ensure all systems and processes meet global GMP and regulatory expectations.
About Your Skills and Experience The candidate should have to following proficiencies:
Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences.
At least 5 years of relevant QA or Qualification experience in a GMP regulated pharmaceutical or biotechnology environment.
Deep understanding of cGMP regulations such as (EU GMP Annex 1, PART IV, ICH, 21 CFR Part 11).
Strong communication skills in English (written and verbal).
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.
Strong analytical thinking, risk assessment and communication skills.
Collaboration and teaming skills.
Preferred Skills:
Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy
Where Molecules Meet Opportunities Hybrid Work
You are eligible to work in EU We only accept applicants who are eligible to work in the EU
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
#J-18808-Ljbffr
Manufacturing Engineering
Facility & Equipment
General
Manufacturing
Quality
Quality
Quality Control
Quality Assurance
Compliance
Quality Systems
Validation
Staff
Procurement & Supply Chain
About the vacancy
Engineering
Manufacturing Engineering
Facility & Equipment
General
Manufacturing
Quality
Quality
Quality Control
Quality Assurance
Compliance
Quality Systems
Validation
Staff
Procurement & Supply Chain
ExpertMaster’s Degree (WO)PermanentFull time Gent, Belgium
About Your Next Job Job Description:
& Johnson Innovative Medicines is recruiting a CAR-T QA C&Q Lead 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 started up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operated from the existing J&J Beerse site.
As the CAR-T Qualification lead, you will play a pivotal role in ensuring the qualification of critical systems, equipment, facilities and utilities used in CAR-T Manufacturing. You will lead a team of QA C&Q engineers and collaborate cross functionally with engineering, maintenance, validation, and operation teams to ensure all systems and processes meet global GMP and regulatory expectations.
About Your Skills and Experience The candidate should have to following proficiencies:
Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences.
At least 5 years of relevant QA or Qualification experience in a GMP regulated pharmaceutical or biotechnology environment.
Deep understanding of cGMP regulations such as (EU GMP Annex 1, PART IV, ICH, 21 CFR Part 11).
Strong communication skills in English (written and verbal).
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.
Strong analytical thinking, risk assessment and communication skills.
Collaboration and teaming skills.
Preferred Skills:
Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy
Where Molecules Meet Opportunities Hybrid Work
You are eligible to work in EU We only accept applicants who are eligible to work in the EU
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
#J-18808-Ljbffr