Automation Engineer

Real; Breda; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an experienced IT/OT Automation Engineer to manage automation systems within a GMP-regulated environment. The role requires overseeing operational technology systems, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. Ideal candidates should have a Bachelor's degree in Engineering or Computer Science and 5+ years of relevant experience. This opportunity provides a chance to work on innovative projects in the Breda / Tilburg Area, Netherlands.

Qualifications

• 5+ years of experience in automation engineering within GMP-regulated environments.
• Strong knowledge of automation systems, computer system validation, and pharma regulatory requirements.

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.

Skills

Automation engineering within GMP-regulated environments

Communication skills

Problem-solving skills

Education

Bachelor's degree in Engineering, Computer Science, or related field

Tools

SCADA systems

WinCC

BMS (Building Management System)

AD/LDAP

VLAN

Job description

IT/OT Automation Engineer

Start: January 2026

Location: Breda / Tilburg Area, Netherlands

Hours: Full-time

Sector: Pharmaceutical / Biotech / Manufacturing Automation

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

Preferred

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

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Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Engineering and Information Technology

Industries

• Pharmaceutical Manufacturing