QA CSV Engineer (medior)

QA CSV Engineer

• Location: Beerse, Belgium

• Duration of the contract: 31 December 2026 (Possible extension)

• Hours per week: 40

Imagine your next project ensuring the ultimate safety, compliance, and data integrity of computerized systems that deliver life-changing innovative medicines to patients worldwide.

We as the QA CSV group belong to the Quality organization of Johnson & Johnson Innovative Medicine Supply Chain (IMSC) and are responsible to ensure the quality and compliance of different systems on the J&J Belgian Campus (including commercial and clinical activities in Beerse, Olen and Geel). To strengthen this team, we are looking for a QA-CSV Engineer (M/F/X), located mainly in Beerse Belgium, with focus on Innovative Medicine Supply Chain systems. The function will allow up to 2 days per week to work at home.

roles and responsibilities 

Provide general support for the QA-CSV team on projects and recurrent activities.

This will involve:

• Assure that all Computer System Validation related regulatory requirements are fulfilled during the complete life cycle of computerized systems (concept, project, operational and retirement phase).

• Act as a process owner of the periodic review process for computerized systems and ensure the timely execution of all planned periodic reviews.

• Review and approve CSV documents such as SOPs, user requirements, risks analysis’s, validation plans, test scripts, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.

• Build and maintain a current knowledge of international laws, guidelines and new evolutions related to CSV. Implement this knowledge to maintain and improve CSV at J&J IMSC.

• Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.

• Provide support to spokespersons for CSV related matters during audits and inspections.

• Provide support during internal and external audits to accomplish regulatory compliance.

• Cooperate with engineering, IT and other teams for the introduction of new systems and processes and for the complete life cycle of the equipment.

• 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.

how to succeed 

Bring your technical expertise, quality-driven mindset, and strong regulatory knowledge to drive validation lifecycle excellence across our multi-functional teams.

You will also bring:

• Master scientific degree or equivalent experience.

• Experienced junior with 2 to 3 years relevant experience or a beginning medior that has around 3 years experience.

• Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines).

• Experience with Computerized System Validation.

• Experience with Data Integrity remediation activities.

• Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

• Strong ownership and Quality mindset with the ability to deliver on commitment timelines.

• Ability to make risk-based decisions and understand the business implications regarding quality positions.

benefits 

This role offers a very competitive hourly rate. This contract will run for 31 december 2026.

you are welcome here 

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine 

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process 

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion 

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.