Senior Process Engineer Biotechnology & Pharmaceutical Manufacturing

The Company
A leading organization in the pharmaceutical and animal health sector, operating across multiple locations in the Netherlands. The company is known for its strong focus on safety, compliance, and innovation within engineering and production environments

Role Description:
We are seeking a highly experienced Senior Process Engineer to oversee the design, installation, and qualification of advanced manufacturing equipment for a major development project. This role focuses on ensuring the safe, compliant, and efficient operation of production facilities within the Beta Lactam formulation area at our client’s site in Boxmeer, the Netherlands.

Responsibilities:
-Lead the engineering design and coordination of complex manufacturing equipment, including formulation vessels, isolators, and auxiliary systems.
-Act as a subject matter expert for the Beta Lactam formulation process, providing technical guidance throughout all project phases.
-Oversee the installation, commissioning, and qualification activities, ensuring all systems meet quality and safety standards.
-Collaborate closely with internal teams across disciplines such as automation, process, mechanical, and civil engineering, as well as external vendors and partners.
-Support factory acceptance testing (FAT) at vendor locations and manage integration of equipment with existing and new systems.
-Maintain strong relationships with project stakeholders, ensuring timely delivery and adherence to project scope.
-Manage technical aspects of the project to facilitate a smooth handover and operational readiness.
-Ensure all activities comply with GMP guidelines, including EU GMP Annex 1, EHEDG, and ISPE standards.

Requirements:
-Bachelor’s or Master’s degree in (Bio)Pharmaceutical, Process, Mechanical Engineering, or a related field.
-Minimum of 5 years’ relevant experience in pharmaceutical, biotech, or high-tech capital projects.
-Proven expertise in complex process engineering, equipment design, and GMP environments.
-Experience with hygienic design, powder handling, and Beta Lactam manufacturing is preferred.
-Strong knowledge of European GMP regulations and guidelines.
-Excellent communication skills in English; Dutch language skills are a plus but not essential.
-Willingness to travel to vendor sites and be on-site in Boxmeer at least three days a week; full-time presence expected during installation and commissioning phases.

Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.

58442