IT/OT Automation Engineer – GMP Pharma & Validation

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

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.