QA CSV and Data Integrity expect

Johnson & Johnson Co.; Oost-Vlaanderen; 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 anniversary awards

Insurance plans

Résumé du poste

Johnson & Johnson in Belgium is seeking 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, and you will provide quality oversight in line with Janssen policies and global cGMP standards for computer system validation and data integrity in manufacturing and lab areas.

You will lead CSV lifecycle activities, audits, and cross-functional collaboration with IT and engineering to ensure compliance and continuous improvement

Qualifications

• Fluent in verbal and written English and Dutch.
• Strong ownership and quality attitude with timely delivery.
• Ability to make risk-based decisions.

Responsabilités

• To assure that all Computer Systems Validation related regulatory requirements are fulfilled during the complete life cycle of computerized systems.
• Act as Process Owner for Computer Systems Validation management.
• Review and approve CSV documents such as SOPs, user requirements, risks analysis, Validation Plans, tests, changes, deviations to maintain compliance.
• Maintain knowledge of international laws and guidelines related to CSV; apply to improve CSV.
• 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 introduction of new systems and processes.
• Be a SME for Data integrity topics.

Connaissances

Fluent English & Dutch communication

Ownership & quality mindset

Risk-based decision making

Team collaboration

Formation

Master scientific degree or equivalent

3 years' pharmaceutical industry experience

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:

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.

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.

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:

• 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
• participation in several insurance plans to employees and eligible dependents (subject to plan terms)

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.