IT-OT Automation Engineer

Progressive; Noord-Brabant; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading firm in pharmaceutical automation is seeking an IT/OT Automation Engineer to manage automation systems within a GMP-regulated environment. This full-time role involves ensuring compliance with regulatory standards and collaborating with cross-functional teams. A Bachelor’s degree in Engineering or Computer Science and over 5 years of experience in automation engineering are essential, as well as strong knowledge of automation systems. The position will be based in the Breda/Tilburg area.

Qualifications

• 5+ years of experience in automation engineering within GMP-regulated environments.
• Strong knowledge of automation systems and computer system validation.
• Experience in biotech manufacturing preferred.

Responsibilities

• Oversee OT systems for automated manufacturing lines.
• Manage the automation lifecycle: configuration, testing, and validation.
• Ensure compliance with FDA cGxP and corporate standards.

Skills

Automation systems

Computer system validation

GMP regulatory requirements

Excellent communication

Problem solving

Education

Bachelor's degree in Engineering or Computer Science

Tools

SCADA systems

Siemens TIA Portal

WinCC

Building Management System (BMS)

Environmental Monitoring System (EMS)

Job description

IT/OT Automation Engineer

Location: Breda / Tilburg Area, Netherlands

Hours: Full-time

Sector: Pharmaceutical / Biotech / Manufacturing Automation

Start: January 2026

Contract: 6‑month contract (extension likely)

About the Role

We are seeking an experienced IT/OT Automation Engineer to oversee the Operational Technology (OT) scope of semi‑automated and automated manufacturing lines. This role involves managing automation systems and computer system validation (CSV) in a GMP‑regulated pharmaceutical environment. You will ensure compliance with GxP standards, support integration with IT systems, and provide technical expertise for automation initiatives.

Key Responsibilities

• Oversee OT systems for automated and semi‑automated manufacturing lines.
• Manage automation lifecycle activities: configuration, testing, documentation, and validation.
• Ensure compliance with FDA cGxP, 21 CFR Part 11, and corporate standards.
• Collaborate with cross‑functional teams to integrate OT systems with IT infrastructure.
• Act as subject matter expert during audits and inspections.
• Develop and maintain SOPs for automation systems and validation processes.
• Drive continuous improvement and standardization across manufacturing sites.

Who We're Looking For

• Bachelor's degree in Engineering, Computer Science, or related field.
• 5+ years of experience in automation engineering within GMP‑regulated environments.
• Strong knowledge of automation systems, computer system validation, and pharma regulatory requirements.
• Excellent communication and problem‑solving skills.

Technical Expertise

• SCADA systems
• WinCC
• BMS (Building Management System)
• AD/LDAP
• VLAN
• Siemens TIA Portal
• EMS (Environmental Monitoring System)

Preferred

• Experience in radiopharmaceutical or biotech manufacturing environments.
• Familiarity with IT/OT cybersecurity best practices.
• Knowledge of network architecture and virtualization technologies.

Seniority level

Entry level

Employment type

Full‑time

Job function

Pharmaceutical Manufacturing

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