Industrial IT Operational Compliance Associate

Industrial IT Operational Compliance Associate

Location: Ghent (Hybrid, 3 days on-site and 2 WFH)

Language requirements: English and Dutch

Duration: Contract running until the end of 2026

Hours: Full-time, 40 hours per week

Imagine your next project playing a central role in guarding the GxP compliance of operational industrial IT assets and bridging the OT and IT worlds at the CAR-T Ghent Sites.

As Industrial IT - Operational Compliance Associate, you play a central role in guarding the GxP compliance of the operational industrial IT assets at the CAR-T Ghent Sites. The Ind. IT assets are OT systems and automation solutions providing digital connectivity of equipment, bridging the OT and IT worlds. As responsible for the daily follow-up, troubleshooting, monitoring and maintenance of operational industrial IT Systems, you will interact with end-users, the IT department and multiple other JnJ/Legend Bio departments to ensure compliance of the assets within the GxP environment. The Industrial IT Operational Compliance Associate is responsible for the daily follow-up, monitoring, and maintenance of operational Industrial IT systems to ensure continued operability and compliance within the GxP environment.

roles and responsibilities

• Plan, perform, and routinely follow up on operational Industrial IT assets:
• Manage, control, and monitor user access
• Follow up on incidents and support service resolution
• Support investigations, deviations, and root cause analyses
• Track CAPAs to ensure compliance and timely closure
• Perform and document audit trail reviews
• Schedule and perform recurring routine OT maintenance tasks (patching, upgrades etc.)
• Document actions taken and solutions implemented
• Identify improvement opportunities and drive efficiency enhancements
• Schedule, prepare, and document weekly, monthly, quarterly, and annual meetings and reports for operational Industrial IT assets
• Prepare and report on weekly team meetings
• Prepare and report on monthly meetings, such as the Change Control Board (CCB)
• Manage changes for existing operational Industrial IT applications:
• Perform impact and risk assessments
• Prepare and execute CSV validation activities, protocols, and test scripts in line with GAMP 5 requirements and the change scope
• Update related SOPs, WIs, and forms for the Industrial IT asset
• Ensure compliance with cGMPs, global regulatory requirements, safety standards, SOPs/WIs, and corporate policies, including Process Automation engineering for Levels 0–2 and integrations with MES at Level 3.
• Uphold documentation standards and GDocP principles
• Support Industrial IT Engineers in writing and executing protocols and procedures
• Standardize general operational Ind. IT processes and update related general SOPs/WI’s/(e)Forms

how to succeed

• Degree in Engineering, IT, Science, or related discipline; Bachelor or Masters.
• Interest/knowledge of IT/OT systems
• Proficient in Microsoft Office and SharePoint.
• In-depth knowledge of current GMP standards and related guidelines, including 21 CFR Part 11, EU GMP Annex 11, Data Integrity, ISA-88, ISA-95, ICH, FDA, FAGG/FAMHP and ISPE guidance.
• In-depth knowledge of GAMP 5 guidelines for computerized systems.
• Knowledge of cybersecurity principles and NIS2 requirements is preferred
• Experience with industrial automation technology and validation standards relevant to the pharmaceutical industry is preferred.
• Experience with SAP and Ticketing systems is preferred
• Experience with Quality Event Management Systems, Document management systems and Change Management systems is preferred.
• Acts in line with Johnson & Johnson’s Credo and Leadership Imperatives, integrating them into daily work and decision-making.
• Prioritizes quality, safety and security in every decision and action.
• Demonstrates strong organizational and scheduling skills
• Works proactively, accurately, well organized and structured
• Has a hands-on mentality and a great eye for detail
• Can independently plan, coordinate, and follow through on work, even under pressure.
• Is an open, collaborative team player with a strong service and problem-solving mindset.
• Takes ownership of assigned systems and tasks, ensuring timely follow-up, escalation, and completion.
• Applies a structured, analytical approach to problem solving
• Communicates clearly and constructively, focusing on solutions and alignment with stakeholders.
• Excellent command of English (spoken and written).
• Strong proficiency in Dutch (C1 level) is preferred.

benefits

This role offers a very competitive hourly rate. This contract will run until the end of 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

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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 or LinkedIn InMail - you must apply direct to this advert.

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”.