Senior Equipment Engineer
SIRE® Life Sciences
Senior Equipment Engineer
Samenvatting
Wat krijg je?
Wat ga je doen?
- Develop detailed engineering design documentation
- Evaluate equipment characterization tests
- Support FAT and SAT testing
- Oversee equipment installation and commissioning
- Manage assigned engineering projects
Wat verwachten wij?
- Degree in Mechanical, Electrical or Chemical Engineering
- Six years experience in manufacturing and operations
- Expertise in equipment design and installation
- Experience working in GMP regulated environments
Volledige vacaturetekst
At this global biotechnology hub in Breda, the Equipment Engineer drives the lifecycle of high-tech production machinery. You will lead design activities and optimize systems for device assembly and packaging while ensuring peak operational efficiency. The role offers a chance to innovate within a GMP environment, where technical mastery meets impactful patient care. Discover how your engineering expertise can shape the future of clinical distribution.
The Company
The company is a global biotechnology company dedicated to improving the lives of patients. In Breda they focus on preparing, planning, and coordinating the shipping and distribution of clinical trial materials.
Role Description
The Equipment Engineer plays a key role in supporting manufacturing operations across Device Assembly, Inspection, Labeling and Packaging. This position manages the full lifecycle of production equipment - from design and installation to optimization and continuous improvement. Working closely with cross-functional teams, the engineer ensures that equipment is reliable, compliant, and performing at peak efficiency. The role also involves troubleshooting technical issues, driving safety and productivity enhancements, and delivering technical projects that support operational excellence.
Responsibilities
- Leading detailed engineering activities and developing design documentation including User Requirements (URS), Functional Specifications (FDS), Hardware Design Specifications (HDS), and Design Reviews (DR) aligned with compliance and operational needs.
- Planning, conducting, and evaluating equipment characterization tests by varying parameters to assess impact on performance and process effectiveness.
- Supporting Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) in collaboration with engineering teams.
- Overseeing equipment installation, testing phases, and commissioning to ensure systems operate effectively and meet quality standards.
- Collaborating with stakeholders to scope equipment-related projects and ensure designs meet required technical and regulatory standards.
- Managing assigned projects, including prioritization, resource coordination, progress tracking, and communication with external partners.
- Diagnosing, troubleshooting, and resolving equipment failures or performance issues.
- Developing technical documentation, specifications, and engineering protocols.
- Participating in Root Cause Analyses and cross-functional problem?solving initiatives within process teams.
- Performing all tasks in accordance with Good Manufacturing Practices (GMP), company procedures, and compliance requirements.
- Maintaining a safe workplace by adhering to environmental, health, and safety regulations.
Requirements
- Bachelor’s degree or higher in Mechanical, Electrical, Chemical Engineering or a related field, or equivalent combination of education and experience.
- Approximately 6+ years of relevant experience, including 4+ years in an operations or manufacturing environment—preferably within pharmaceuticals or automated device assembly, labeling, and packaging.
- Strong expertise in equipment design, installation, commissioning, and maintenance.
- Solid disciplinary knowledge within their engineering specialty.
- Hands-on experience working in regulated environments (e.g., GMP, OSHA, EPA).
- Willingness to occasionally work outside standard office hours.
- Fluent written and spoken English.
- Proficiency in MS Office and general computer applications.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
57325
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