QA CSV and Data Integrity expect

Johnson & Johnson Innovation; Antwerpen; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health programs

Service awards

Insurance plans

Résumé du poste

Johnson & Johnson Innovation seeks a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe. Based in Ghent or Beerse, you will oversee CSV quality and data integrity in manufacturing and labs, ensuring cGMP compliance and effective audits.

You will partner with IT, engineering, and other teams to validate systems and protect data integrity while supporting multi-functional projects in a dynamic biopharma environment.

Qualifications

• Master's degree or equivalent in a scientific field or related discipline.
• 3 years’ experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; EU Directive 2003/94/EC and annex 11; GAMP, Data Integrity Guidelines).
• Experience with Computerized System Validation and regulatory audits.

Responsabilités

• Assure CSV regulatory requirements are fulfilled across the life cycle of computerized systems.
• Act as Process Owner for CSV management and document reviews (SOPs, URs, risks, validation plans, tests, changes, deviations).
• Maintain knowledge of international CSV guidelines and drive improvements.
• Prepare for computer system audits and inspections; represent CSV during audits.
• Collaborate with engineering, IT and other teams on new systems and processes.
• Provide advice on CSV activities; support cross-functional projects; be a Data Integrity SME.

Connaissances

CSV engineer

Data integrity

Quality oversight

Audits & inspections

Regulatory compliance

English & Dutch

Formation

Master's degree or equivalent

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.

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: Professional

All Job Posting Locations: Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium

Job Description

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 The Advanced Therapy Quality team from Johnson & Johnson Innovative Medicine, is recruiting a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe. The position will be based in Ghent or Beerse Belgium.

The QA CSV engineer and data integrity expert is responsible for providing quality oversight in accordance with Janssen policies, standards, procedures, and Global cGMP’s for computer system validation and data integrity in manufacturing and lab area’s.

Key Responsibilities

• To assure that all Computer Systems Validation related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) of computerized systems.
• Act as Process Owner for Computer Systems Validation management.
• Review and approve CSV documents such as SOPs, user requirements, risks analysis’s, Validation Plans, tests, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Computer Systems Validation at Janssen.
• Prepare for computer system audits and inspections.
• Be the spokesperson for CSV related matters during audits and inspections.
• Perform and follow up on internal and external audits to accomplish regulatory compliance.
• Cooperate with engineering, IT and other teams for the introduction of new systems and processes.
• To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.
• Be a SME for Data integrity topics

Qualifications

Education:

• Master scientific degree or equivalent experience.
• 3 years’ experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; EU Directive 2003/94/EC and annex 11; GAMP, Data Integrity Guidelines)
• Experience with Computerized System Validation.
• Strong ownership and quality attitude. You are able to deliver on commitment timelines.
• Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
• Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

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.

Here’s what you can expect:

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

Required Skills:

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

The anticipated base pay range for this position is:

€60.000,00 - €96.255,00

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
• 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
• service anniversary and recognition awards
• employees - and in some location’s eligible dependents - can participate in several insurance plans

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.