About the vacancy
Quality (Engineering)
Environmental, Health & Safety
General
Quality
Quality Control
Quality Assurance
Compliance
Validation
Project Management
About Your Next Job
About CAR-T
CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. The patients’ own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen.
To bring this life saving therapy to the patients, Johnson & Johnson Innovative Medicine is looking for new talents to support the QA CSV organisation! So don't hesitate, the patients are waiting!
The QA CSV engineer CAR-T is responsible for providing quality oversight for computer system validation activities in accordance with Janssen policies, standards, procedures, and Global cGMP’s.
We are searching for the best talent for a QA CSV engineer for the CAR-T hub in Europe, based in Ghent, Belgium.
About Your Tasks and Responsibilities
You are responsible for:
- 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.
About Your Skills and Experience
Qualification / Requirements:
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.
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
Where Molecules Meet Opportunities
Hybrid Work
You are eligible to work in EU
We only accept applicants who are eligible to work in the EU
Contact person
Pieter Smans
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 https://www.jnj.com