Job Description :
In our production departments
Raw materials are transformed into filled medicines. The product passes through several production steps — weighing, formulation, preparation, freeze-drying, filling, capping, inspection, storage, and transport. At each stage, production strives for the highest level of operational excellence. Further along the production process, the medicine is labeled and packaged before being distributed through the supply chain to reach the patient.
Within the Engineering Department
We are responsible for the realization of various projects. As a
Project Engineer Utilities – Validation
, the consultant acts as a key validation contact within the Utilities team. The consultant prepares and reviews all validation documents and provides support to various Project Engineers across multiple projects. They are actively involved in assessing validation optimization opportunities and implementing evolving regulatory requirements.
Systems such as
MIR, CAPA, and CRF
are well known to the consultant, as they will need to work regularly within these systems to ensure no overdue actions are assigned to the Utilities team.
The Utilities team is responsible for executing projects from design through to final delivery (basic and detailed design, procurement, construction, start-up, and validation). The Utilities supplied to the production process mainly include
clean utilities
(direct impact compressed air, clean steam, water for injection, nitrogen) and additional
black utilities
(steam, city water, cooling water, nitrogen, vacuum, etc.). The utilities may include generation, storage, and distribution systems.
Scope of Work :
* Acts as the main validation contact within the Utilities team.
* Supports the Project Engineer with all documentation.
* Defines a clear validation strategy from the start of each project.
* Prepares a detailed schedule aligned with the overall project or operational planning.
* Contributes to quality optimization initiatives.
* Develops expertise to act as a
Subject Matter Expert (SME)
.
* Ensures accurate and compliant documentation.
* Capable of independently following up on smaller projects.
Experience :
Must-have:
* Excellent command of Dutch and English.
* Strong communication skills.
* Strong administrative skills.
* Critical eye for detail.
* Organized and accurate working style.
* Ability to work independently.
* Knowledge of GMP.
Nice to have:
* Enthusiastic team player.
* Experience in a similar role within a GMP environment is a strong plus.
* Technical knowledge of Utilities.
* Experience in project-based work.