Industrial IT Operational Compliance Associate

MindCapture

Belgique

Sur place

EUR 65 000 - 90 000

Plein temps

Il y a 5 heures
Soyez parmi les premiers à postuler
Générateur de candidature

N’envoyez pas un CV générique — générez un CV et une lettre de motivation adaptés à ce poste précis.

Passez les filtres ATS

Avantages offerts par ce poste

Meal vouchers
Eco vouchers
Health insurance
Group insurance
Net expense allowance
Company car with charging or fuel card

Résumé du poste

MindCapture seeks an Industrial IT Operational Compliance Associate to maintain GxP compliance and operability of industrial IT assets on-site with top healthcare institutions in Belgium. You will monitor, validate, and document systems, collaborate with IT, OT, engineering and quality stakeholders, and contribute to quality events and continuous improvement.

The role focuses on daily operations, access controls, validation activities, and adherence to GMP and data integrity standards, with a

Qualifications

  • Bachelor or Master in Engineering, IT, Science or related discipline.
  • GMP knowledge and pharmaceutical guidelines understanding.
  • GAMP 5 principles for computerised systems knowledge.
  • Familiarity with electronic records, data integrity and regulated systems.
  • Interest or knowledge of industrial IT and OT systems.
  • Proficiency with Microsoft Office and SharePoint.

Responsabilités

  • System monitoring of industrial IT assets to maintain operability and compliance.
  • Manage, control and monitor user access across systems.
  • Support incidents, investigations, deviations, root cause analyses and CAPAs.
  • Perform and document audit trail reviews.
  • Schedule and perform maintenance including patching and upgrades.
  • Assess impact and risk for changes to industrial IT apps.
  • Prepare and execute validation activities per GAMP 5.
  • Update procedures and system documentation with good practices.
  • Maintain alignment with GMP requirements, data integrity and regulatory standards.
  • Identify opportunities for process improvement and efficiency.

Connaissances

GMP knowledge
Validation knowledge
Regulatory knowledge
IT and OT
Cybersecurity
English
Dutch

Formation

Bachelor or Master degree in Engineering, IT, Science

Outils

Microsoft Office
SharePoint

Description du poste

Jobs / Industrial IT Operational Compliance Associate
Industrial IT Operational Compliance Associate

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

  • A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
  • Personal growth support with tailored training and clear career development
  • A stable environment where your technical skills directly contribute to improved patient care
  • The chance to work with high tech diagnostic systems at top tier healthcare institutions
  • A warm and collaborative culture focused on trust, ownership and long term impact

You will play a central role in maintaining the GxP compliance and continued operability of industrial IT assets connecting operational technology with wider IT environments. Your work covers daily monitoring, troubleshooting, maintenance, access management, quality events, validation and controlled changes. You will collaborate with end users, IT specialists, engineers and quality stakeholders while maintaining strong documentation, safety and compliance standards.

Key responsibilities

  • System monitoring: Perform daily follow up and monitoring of operational industrial IT assets to maintain operability and compliance
  • Access management: Manage, control and monitor user access across relevant operational systems
  • Quality events: Support incidents, investigations, deviations, root cause analyses and corrective and preventive actions
  • Audit trails: Perform and document audit trail reviews according to applicable requirements
  • System maintenance: Schedule and perform recurring operational technology maintenance including patching and upgrades
  • Change management: Perform impact and risk assessments for changes to existing industrial IT applications
  • Computerised system validation: Prepare and execute validation activities, protocols and test scripts according to GAMP 5 principles
  • Documentation: Update procedures, work instructions, forms and system documentation while applying good documentation practices
  • Compliance oversight: Maintain alignment with current GMP requirements, data integrity expectations and applicable regulatory standards
  • Process improvement: Standardise operational processes, identify improvement opportunities and support greater efficiency
Required competences & skills
  • Education: Bachelor or Master degree in Engineering, IT, Science or a related discipline
  • GMP knowledge: In depth understanding of current GMP requirements and relevant pharmaceutical guidelines
  • Validation knowledge: In depth knowledge of GAMP 5 principles for computerised systems
  • Regulatory knowledge: Familiarity with requirements covering electronic records, data integrity and regulated computerised systems
  • IT and OT: Interest or knowledge of industrial IT and operational technology systems
  • Digital tools: Proficiency with Microsoft Office and SharePoint
  • Automation: Experience with industrial automation technology and pharmaceutical validation standards is a plus
  • Quality systems: Experience with enterprise systems, ticketing tools, quality event systems, document management or change management systems is a plus
  • Cybersecurity: Knowledge of cybersecurity principles and NIS2 requirements is a plus
  • Languages: Excellent spoken and written English while strong Dutch proficiency at C1 level is a plus
Quality & Compliance Antwerp Medior At MindCapture as consultant
About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.

Explore other jobs in Quality & Compliance
  • Support global change controls for manufacturing processes
  • Coordinate stakeholders across quality and operations
  • Enable tech transfers and continuous improvement
  • Drive process verification within cell therapy manufacturing
  • Analyse manufacturing data to identify trends
  • Strengthen governance through monitoring and investigation
  • Maintain compliant industrial IT systems within operations
  • Coordinate validation, maintenance and investigations
  • Bridge operational technology, IT, quality and business
  • Review qualification documentation using risk based methods
  • Support compliance, investigations, audits and CI
  • Perform quality control within a regulated environment
  • Analyse samples using analytical techniques
  • Ensure accurate documentation while following GMP
  • Take ownership of broad QA responsibilities in GMP
  • Manage deviations, audits and compliance related activities
  • Drive quality improvements through investigations
  • Provide quality oversight for cleaning validation activities
  • Ensure compliance across validation processes
  • Guide stakeholders on risk based quality decisions effectively
  • Lead quality assurance in a growing biopharma environment
  • Strengthen compliant quality systems
  • Guide audits and improvement initiatives
  • Execute validation of GMP critical computerised systems
  • Ensure compliance with FDA and EU regulatory standards
  • Generate validation documentation and resolve issues
  • Maintain and troubleshoot lab equipment in GMP setting
  • Ensure compliance with cGMP standards and safety guidelines
  • Support upgrades and continuous improvement initiatives
  • Perform QC testing for cell therapy products
  • Ensure compliance with GMP and regulatory standards
  • Collaborate on tech transfer and quality documentation
  • Drive quality strategy for global computerised systems
  • Ensure validation in line with GMP requirements
  • Lead audits, inspections and compliance risk assessments
  • Build, implement and maintain Quality Management Systems
  • Manage deviations, CAPAs and change control processes
  • Prepare for and support audits and inspections

We know timing is everything. If you don’t see a role that fits you right now, we still want to hear from you. Our consultants are always looking for talent, sometimes before the job even goes live.

Obtenez votre examen gratuit et confidentiel de votre CV.
ou faites glisser et déposez votre fichier ici.
Similar jobs

Postes similaires à comparer

Quality Control Analyst
Quality Control Analyst

MindCapture • Belgique

Sur place
EUR 42 000 - 65 000
Meal vouchers
Eco vouchers
Health insurance
+3
QA Manager
QA Manager

MindCapture • Belgique

Sur place
EUR 90 000 - 130 000
Meal vouchers
Health insurance
Company car with charging or fuel card
+2
QA Equipment Qualification Engineer
QA Equipment Qualification Engineer

MindCapture • Belgique

Sur place
EUR 65 000 - 85 000
Meal vouchers
Eco vouchers
Health insurance
+3
QA Engineer
QA Engineer

MindCapture • Belgique

Sur place
EUR 55 000 - 75 000
Meal vouchers
Eco vouchers
Health insurance
+5
Process Validation Engineer Cell Therapy
Process Validation Engineer Cell Therapy

MindCapture • Belgique

Sur place
EUR 70 000 - 90 000
Meal vouchers
Eco vouchers
Health insurance
+3
Industrial IT Compliance & Validation Specialist
Industrial IT Compliance & Validation Specialist

MindCapture • Belgique

Sur place
EUR 65 000 - 90 000
Meal vouchers
Eco vouchers
Health insurance
+3
Sr Quality Engineer Cleaning Validation
Sr Quality Engineer Cleaning Validation

MindCapture • Belgique

Sur place
EUR 90 000 - 120 000
Meal vouchers
Eco vouchers
Health insurance
+3
Operations Supervisor
Operations Supervisor

MindCapture • Oost-Vlaanderen

Sur place
EUR 55 000 - 85 000
Meal vouchers
Eco vouchers
Health insurance
+3
QC Analyst
QC Analyst

MindCapture • Belgique

Sur place
EUR 42 000 - 60 000
Competitive salary package
Permanent contract
Meal vouchers
+5
CSV Engineer Infrastructure
CSV Engineer Infrastructure

MindCapture • Belgique

Sur place
EUR 90 000 - 130 000
Meal vouchers and eco vouchers
Health insurance
Group insurance
+5