IT-OT Automation Engineer

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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