Pharma PCS7 Automation Engineer – GMP & Validation

Nalys; Henegouwen; On-site; EUR 65,000 - 90,000; Full time

Job summary

Nalys, a growing consultancy, seeks an Automation Engineer to join the automation and engineering team at a leading biopharmaceutical manufacturer in Belgium. You will design, program, test, and qualify PCS 7 applications, from functional specs through to handover to operations, in a strictly regulated environment.

Reporting to the automation lead, you will collaborate with production, engineering and quality to ensure process reliability and compliance.

Qualifications

• Bachelor's or master's degree in automation, electromechanics, electrical engineering, or a related field.
• Minimum 5 years' experience in industrial automation, preferably GMP-regulated.
• Experience with Siemens PCS 7 including CFC/SFC and WinCC.
• Familiar with GAMP 5, 21 CFR Part 11, EU GMP Annex 11.
• Understanding instrumentation, P&IDs, and electrical schematics.
• Fluent in French and working knowledge of English.
• Clear and effective communication with technical and non-technical stakeholders.
• Structured, problem-solving mindset in a dynamic environment.

Responsibilities

• Translating process and user requirements into functional and design specifications
• Developing and modifying PCS 7 applications
• Configuring controllers, remote I/O, and industrial networks
• Preparing and executing FAT, SAT, and commissioning activities
• Supporting qualification and IQ/OQ validation
• Troubleshooting automation issues and providing second-line support to production
• Managing changes, deviations, and CAPAs related to automated systems
• Contributing to system upgrades, migrations, and lifecycle management
• Coordinating with integrators and suppliers on scope, quality, and timelines
• Writing and maintaining technical documentation and procedures
• Training operators and technicians on new or modified functionalities.

Skills

Industrial automation

GMP manufacturing

French language

English communication

Structured problem solving

Stakeholder communication

Project coordination

Education

Bachelor's/Master's in automation/electromechanics/electrical engineering

Tools

Siemens PCS 7

CFC/SFC programming

WinCC visualization

P&IDs

Electrical schematics

Job description

Nalys, a growing consultancy, seeks an Automation Engineer to join the automation and engineering team at a leading biopharmaceutical manufacturer in Belgium. You will design, program, test, and qualify PCS 7 applications, from functional specs through to handover to operations, in a strictly regulated environment.

Reporting to the automation lead, you will collaborate with production, engineering and quality to ensure process reliability and compliance.