QC Micro analist weekend

Johnson & Johnson; Belgique; Sur place; EUR 43 000 - 59 000; Plein temps

Résumé du poste

Johnson & Johnson Beerse, Belgium, is seeking a QC Micro Analyst, CAR-T Europe, to perform and review microbiological testing supporting CAR-T production in a cGMP QC lab. The role emphasizes data integrity, compliance, and patient safety, with weekend shifts Saturdays and Sundays 6:00 AM–6:00 PM.

You will maintain SOPs, assist with investigations and CAPAs, and collaborate across functions while ensuring testing aligns with USP/EP/JP standards and regulatory requirements.

Qualifications

• Bachelor's degree in a Scientific discipline or related field.
• Minimum of 2 years of experience in a cGMP-compliant Quality Control laboratory or similar regulated environment.
• Strong understanding of microbiological testing principles and interpretation of microbiological data.
• Experience with microbiological laboratory techniques, including aseptic practices, endotoxin testing, growth promotion testing, sterility testing, and environmental monitoring.
• Knowledge of compendial requirements (USP, EP, JP) is preferred, along with proficiency in Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Excellent written and verbal communication skills; prior CAR-T, cell therapy, or biopharmaceutical experience is highly desirable.

Responsabilités

• Perform microbiological testing and analytical activities in compliance with GMP regulations, approved procedures, and quality specifications.
• Review laboratory data to ensure accuracy, completeness, compliance, and data integrity.
• Author, revise, and maintain SOPs, Work Instructions (WIs), and laboratory protocols within the document management system.
• Support laboratory investigations, deviations, CAPAs, and other quality-related activities.
• Assist with internal audits and maintain inspection readiness within the QC Microbiology laboratory.
• Participate in laboratory and cross-functional meetings, providing technical input and representing the QC team when required.

Connaissances

Microbiological testing principles

Aseptic practices

Endotoxin testing

Growth promotion testing

Sterility testing

Environmental monitoring

Data interpretation

Formation

Bachelor's degree in a Scientific discipline

Outils

MS Office

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:

Non-Standard

Job Sub Function:

Workday Associate B

Job Category:

Non-Standard

All Job Posting Locations:

Beerse, Antwerp, 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

Job Description

The QC Micro Analyst, CAR-T Europe is responsible for preparing, performing, and reviewing microbiological testing activities that support the production of CAR-T therapies. Working within a cGMP-compliant Quality Control laboratory, the analyst ensures that all testing is conducted in accordance with approved procedures, regulatory requirements, and quality standards. The role supports laboratory operations through microbiological analysis, documentation management, investigations, audits, and cross-functional collaboration, while maintaining a strong focus on data integrity, compliance, and patient safety. This position is part of the weekend team, working Saturday and Sunday from 6:00 AM to 6:00 PM.

Key Responsibilities

• Perform microbiological testing and analytical activities in compliance with GMP regulations, approved procedures, and quality specifications.
• Review laboratory data to ensure accuracy, completeness, compliance, and data integrity.
• Author, revise, and maintain SOPs, Work Instructions (WIs), and laboratory protocols within the document management system.
• Support laboratory investigations, deviations, CAPAs, and other quality-related activities.
• Assist with internal audits and maintain inspection readiness within the QC Microbiology laboratory.
• Participate in laboratory and cross-functional meetings, providing technical input and representing the QC team when required.

Requirements

• Bachelor's degree in a Scientific discipline or a related field.
• Minimum of 2 years of experience in a cGMP-compliant Quality Control laboratory or a similar regulated environment.
• Strong understanding of microbiological testing principles and interpretation of microbiological data.
• Experience with microbiological laboratory techniques, including aseptic practices, endotoxin testing, growth promotion testing, sterility testing, and environmental monitoring.
• Knowledge of compendial requirements (USP, EP, JP) is preferred, along with proficiency in Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Excellent written and verbal communication skills; prior CAR-T, cell therapy, or biopharmaceutical experience is highly desirable.

Required Skills:

Preferred Skills:

The anticipated pay range for this position, in the primary posting location, is:

€0,00 - €0,00

The anticipated pay ranges for additional locations are:

Belgium – The anticipated base pay range for this position is EUR 43435.00 - EUR 58765

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.