Job description
1. Mission Context
We are looking for a Process Engineer with a strong focus on Dry Forms, mainly related to the manufacturing of film-coated tablets.
The role sits at the crossroads of process engineering, industrial automation, and IT, in a GxP-regulated pharmaceutical/medical environment.
You are not expected to be a pure IT specialist, but you must be able to understand and interact with technical systems and stakeholders:
* Good understanding of industrial automation principles:
o PLC, DCS, HMI
o Data flows between systems
* Ability to interact with IT environments:
o Virtualized environments (VMs)
o Networks
o Cybersecurity basics
o Data integrity & access management
* Understanding and integration of GxP constraints and Computer System Validation (CSV) activities
The key expectation is a process-oriented engineer who can:
* Understand technical challenges
* Interface effectively with industrial, automation, and IT teams
* Operate comfortably in a regulated environment
Team setup:
* ~10 Process Engineers (internal & external)
* Position: External consultant, fully integrated into the team
* Potential mentoring responsibilities depending on seniority
2. Key Responsibilities
Process Support – Manufacturing Units
* Provide process support mainly for:
o Medical Device Assembly & Packaging(priority)
o Solid dosage forms / tablets (e.g., blister lines)
* Ensure robust, efficient, and compliant manufacturing processes on the shop floor.
Implementation of New Solutions
* Contribute to the implementation of new equipment
* Support new processes and/or new product introductions
* Participate in risk assessments, trials, and process optimization activities
Operational Support
* Lead or support process troubleshootingon the shop floor
* Perform deviation analysisand define appropriate actions
* Contribute to CAPAs related to process issues, ensuring timely and effective closure
Project Activities
* Act mainly as Process Subject Matter Expert (SME)in cross-functional projects
* Occasionally act as Project Lead for:
o Small-budget projects
o Process change controls or minor equipment modifications
Cross-Functional Collaboration
* Work closely with:
o Production(very hands-on role, daily presence on the shop floor)
o Quality(deviations, CAPAs, validation, documentation)
o Development, especially Packaging Development
o Suppliers (FAT, equipment reception, technical discussions)
Shop-Floor Involvement
* Active presence on the shop floor:
o Testing and trials
o Start-up and optimization of equipment
o Taking ownership of machines from a process perspective
3. Must-Have Requirements
Experience & Technical Background
* Experience in an industrial production environment
* Pharmaceutical or food industryexperience strongly preferred
* Solid process manufacturing expertise, ideally in:
o Packaging / Assembly
o Blister lines or similar continuous/packaging processes
* Ability to:
o Challenge equipmentand suppliers from a process point of view
o Define, understand, and optimize processes, not only execute Q&V tests
IT & Automation Literacy
* Understanding of industrial automation(PLC, DCS, HMI, data flows)
* Comfortable interacting with IT/OT interfaces(VMs, networks, cybersecurity basics, data integrity, access management)
* Familiarity with GxP and CSV constraints
Languages
* French mandatory (daily interactions with local production & quality teams)
* English very important (suppliers, development teams, documentation)
Soft Skills
* Strong and proactive communicationwith shop-floor and cross-functional stakeholders
* Adaptabilityto multiple stakeholders and changing priorities
* Autonomywith regular, structured reporting (manager is often remote)
* Team-oriented, collaborative mindset
4. Nice-to-Have
* Experience with:
o Medical Devices
o Packaging line revampingor modernization projects
o Equipment qualification / validation with a strong process-driven approach
* Previous interaction with Packaging Developmentteams
* Strong sensitivity to:
o Product quality
o Patient impact
o HSE (Health, Safety & Environment) requirements
5. Ideal Candidate Profile
* Background as a Process Engineer (or similar) with a strong shop-floor & production mindset
* Comfortable:
o Working on site, close to the equipment and operators
o Interacting daily with operational teams
o Operating in a highly project-driven environment
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.