Graduate Process Engineer

Job Summary  The Process Engineer, Global Technical Operations / Life Cycle Management (GTO/ LCM), is an individual contributor who is responsible for providing engineering and technical support for production and processing equipment. He/she will manage and assist in the technical qualification of processes, aid in the resolution of engineering technical issues that may require the development of new or improved techniques or procedures, and lead related activities for designated commodities.

The position provides technical leadership for manufacturing processes and equipment. He/she will support a Senior or Staff engineer under the direction of an Engineering manager for the technical qualifications for medical device process development and validation for clinical articles and commercial manufacturing lines, including scoping, designing, executing, data analysis, deviations investigation and providing technical support to supply chain stakeholders. The role is responsible for the Life Cycle Management (LCM) of Nijmegen ETHIZIA manufacturing process and will serve under the guidance of an Engineering Manager and/or Subject Matter Expert (SME).

Key Responsibilities   Provide end-to-end technical support for medical device process development, scale‑up, and validation (clinical and commercial), including process characterization, risk management, and ongoing performance optimization.
Lead and support continuous improvement initiatives, capacity expansion, validation remediation, and technology roadmap development for manufacturing processes.
Collaborate cross‑functionally with R&D, Quality, and external suppliers to support product development, technology transfer, and lifecycle management; act as liaison for process development and supplier qualification.
Design experiments, apply statistical analysis, and generate technical reports to support decision‑making and process improvements.
Execute and support equipment and process validation activities (URS, FAT/SAT, IQ/OQ/PQ), including authoring and reviewing protocols and reports in compliance with GMP and ISO standards.
Investigate process deviations, resolve technical issues, and drive projects to improve quality, yield, and supply chain performance.
Manage and communicate technical (and some business) risks, issues, and opportunities to stakeholders and leadership.
Ensure compliance with health, safety, environmental, and regulatory requirements; perform additional duties as needed.
Essential Qualifications   Bachelor’s degree (or equivalent) in Engineering or a related scientific field (Mechanical, Manufacturing, Biomedical, or Chemical preferred).
Minimum 1–2 years of relevant professional or internship experience.
Good project management skills.
Good communication skills.
Desirable Qualifications   Strong project management, communication, and cross‑functional collaboration skills.
Experience or exposure to process engineering activities, including process development, scale‑ups, cost improvement projects (CIPs), troubleshooting, CAPA, change control, and process qualification.
Familiarity with equipment specification and validation (URS, FAT/SAT, IQ/OQ/PQ).
Working knowledge of statistical analysis (e.g., Minitab), Design of Experiments (DoE), and Six Sigma methodologies.
Proficiency in MS Office applications (including MS Project).
Knowledge of manufacturing processes in regulated industries (medical devices, pharmaceuticals, biologics), including device assembly, chemical, or drug product processes.
Ability to investigate and resolve technical and operational issues, including customer complaints, using root cause analysis and risk management tools.
Experience authoring and reviewing technical documentation for validation and compliance.
Ability to manage projects aligned with quality improvement, cost reduction, cycle time optimization, and capacity increases.
Experience supporting product launches and technology/process transfers in collaboration with cross‑functional teams.
Familiarity with cleanroom environments, supplier coordination (RFQs, ordering), and equipment qualification (advantage).
Strong understanding of regulatory, quality, health, safety, and environmental compliance requirements.
Working knowledge of technical documentation control and retention processes.

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