QA CSV and Data Integrity expect

Johnson Johnson; Gent; On-site; EUR 65,000 - 90,000; Full time

Job summary

Johnson & Johnson is recruiting a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe, based in Ghent or Beerse, Belgium. This role provides quality oversight in line with Janssen policies and global cGMPs for computer system validation and data integrity in manufacturing and laboratory areas.

You will act as CSV process owner, coordinate audits, and collaborate with IT, engineering, and cross-functional teams to ensure compliance and continuous improvement in data integrity

Qualifications

• Master's degree or equivalent experience in a relevant field.
• 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.

Responsibilities

• Assure that CSV-related regulatory requirements are fulfilled across the full life cycle of computerized systems.
• Act as Process Owner for CSV management.
• Review CSV documents (SOPs, URs, risk analyses, Validation Plans, tests, changes, deviations) to maintain compliance.
• Prepare for computer system audits and inspections; be the spokesperson during audits.

Skills

CSV & cGMP

Quality Assurance

Data Integrity

English & Dutch

Education

Master's degree

Job description

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.

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