Automation Qualification Engineer

Nalys; Wallonië; On-site; EUR 60,000 - 90,000; Full time

Job summary

Nalys is seeking an Automation Qualification Engineer to join a major biopharmaceutical project. You will perform IOQ activities on the AVEVA System Platform/ArchestrA environment, ensuring strict GDP/ALCOA+ data integrity and compliant documentation.

You will work hands-on in a GMP setting, collaborating with automation, validation, and QA teams to drive execution and reporting, with a focus on timely delivery and reliability.

Qualifications

• Proven experience executing IOQ protocols in GMP environments.
• Hands-on knowledge of AVEVA System Platform / ArchestrA.
• Ability to retrieve configuration evidence from IDE and Galaxy.
• Familiarity with GAMP 5 and computerized system validation requirements.
• High level of documentation rigor and autonomy.
• Operational immediately in fast-paced project environments.
• Fluent in French and good command of technical English.
• Experience on a large biopharma production site is a strong asset.

Responsibilities

• Executing pre-approved IOQ protocols on the AVEVA System Platform / ArchestrA control system.
• Collecting test evidence directly in the system, covering configuration, HMI, alarms, historization, and security.
• Documenting results in line with GDP and ALCOA+ data integrity principles.
• Identifying, documenting and following up on deviations through to closure.
• Contributing to qualification reports and supporting the validation lifecycle.
• Working closely with automation, validation and QA stakeholders to keep the project on schedule.

Skills

IOQ execution

AVEVA ArchestrA

GAMP5 knowledge

Autonomy

Documentation rigor

English (technical)

French fluency

Tools

AVEVA System Platform

ArchestrA

Job description

About Nalys

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.

Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As an Automation Qualification Engineer, you will join a large-scale qualification project on a major biopharmaceutical production site.

A new process control system is being deployed in a GMP manufacturing building, and we are looking for an automation engineer to carry out its Installation and Operational Qualification (IOQ).

This role is hands-on and execution-driven. You will run pre-approved test protocols directly in the AVEVA System Platform (ArchestrA) environment and gather test evidence independently. You will make sure every result meets the highest documentation and data integrity standards.

We’re looking for a rigorous and autonomous qualification professional who feels at home in a SCADA environment. You should be able to hit the ground running from day one.

The Role & Responsibilities

Working alongside automation, validation and quality teams, your responsibilities will include:

• Executing pre-approved IOQ protocols on the AVEVA System Platform / ArchestrA control system


• Collecting test evidence directly in the system, covering object configuration, HMI screens, alarms, historization, and security and access management


• Documenting results in line with Good Documentation Practices (GDP) and ALCOA+ data integrity principles


• Identifying, documenting and following up on deviations through to closure


• Contributing to qualification reports and supporting the overall validation lifecycle


• Working closely with automation, validation and QA stakeholders to keep the project on schedule.

Skills & Qualifications

• You have proven experience executing IOQ protocols on automated systems in a GMP environment


• You have hands‑on knowledge of AVEVA System Platform / ArchestrA (Wonderware)


• You can navigate the IDE and the Galaxy on your own to retrieve configuration evidence


• You are familiar with GAMP 5 and computerized system validation requirements


• You bring a high level of documentation rigor and a strong sense of autonomy


• You are operational immediately and comfortable in fast‑paced project environments


• You are fluent in French and have a good command of technical English


• Experience on a large biopharmaceutical production site is a strong asset.

The Recruitment Process

By applying for the “Automation Qualification Engineer” position, you will go through the following steps in our recruitment process:

• Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening


• You will have a second interview with one of our Technical Experts


• The last interview will be with our Business Unit Director, Alexandre Ivankovich.