QA CSV and Data Integrity expect

7555-Janssen Pharmaceutica NV Legal Entity; Oost-Vlaanderen; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days and parental leave

Well-being programs

Résumé du poste

Johnson & Johnson Innovative Medicine is recruiting a QA CSV engineer and Data Integrity expert for the CAR‑T hub in Europe, based in Ghent or Beerse, Belgium. You will ensure CSV lifecycle compliance, review validation docs, and prepare for audits.

Fluent English and Dutch are required; 3 years in pharma plus CGMP/CSV knowledge are essential to drive quality across cross‑functional teams.

Qualifications

• Education: Master scientific degree or equivalent experience.
• 3 years’ experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance and related guidelines.
• Experience with Computerized System Validation.
• Fluent English and Dutch communication.

Responsabilités

• Ensure CSV regulatory requirements across full lifecycle.
• Act as Process Owner for CSV management.
• Review CSV documents to maintain compliance.
• Maintain knowledge of CSV regulations and industry trends.
• Prepare for audits and inspections; be a spokesperson.
• Collaborate with engineering and IT on new systems.

Connaissances

Quality Management

Regulatory Knowledge

CSV Compliance

Data Integrity

Audits

Problem Solving

Process Orientation

Quality Standards

Continuous Improvement

GMP

Team Collaboration

Risk Management

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.

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

Job Category: Professional

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

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.

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.

Required 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

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

Salary

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.
• 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.