GTO LCM Senior Process Engineer

Job Summary  At Johnson & Johnson, we believe health is everything. We provide an inclusive work environment where each person is considered as an individual and we respect the diversity and dignity of all employees. The Process Engineer, Global Technical Operations / Life Cycle Management (GTO / LCM), is an individual contributor responsible for providing engineering and technical support for complex production and processing equipment.

The role manages and maintains the technical qualification of external manufacturers and their processes, resolves medium to complex technical issues, develops new or improved techniques, and leads related activities for designated commodities. It provides technical leadership, project management, and mentoring to junior engineers.

Key Responsibilities   Provide end‑to‑end technical support for medical device process development and validation for clinical articles and commercial manufacturing lines.
Lead process characterization activities and own process risk management, performance, and capability.
Drive continuous optimisation to sustain a healthy technology roadmap for the ETHIZIA manufacturing process.
Own scale‑up, validation remediation, and capacity upscaling at the Nijmegen site.
Act as liaison for process development, collaborating with R&D and DQE.
Serve as the technical lead in managing multiple small to large scale projects, coordinating internal and external resources to achieve project goals.
Support external manufacturers by managing the qualification of supplier products and processes, analysing and resolving supplier technical issues, and providing leadership and coaching.
Partner with R&D and QDE communities to provide technology assessment and supplier technical support, support new product development, design and oversee experiments, apply statistical analyses and prepare technical reports.
Lead cross‑functional teams in critical projects of major impact on business unit sales and profitability, support Operations Management in leading tactical activities sustaining corporate initiatives.
Communicate business‑related issues or opportunities to next‑level management.
Perform technical efforts involving scoping, executing, data collection, reporting of studies and investigating deviations in collaboration with cross‑organisational functions.
Follow all company guidelines related to Health, Safety and Environmental practices.
Perform other duties as assigned.
Experience and Education   Minimum of a bachelor’s degree (or equivalent university degree) with a focused degree in Engineering or Science;
Master’s preferred.
Five (5) years of relevant professional work experience.
At least three (3) years of experience in process engineering (product development, scale‑ups, cost‑improvement projects, complex process issue resolution, CAPA management, change‑control management, process qualification).
Good basis in statistical analysis of data – e.g., experience with Minitab or equivalent.
Good basis in engineering principles related to the process of medical devices or pharmaceuticals.
Full proficiency in MS Office applications (including MS Project).
Design of experiment (DOE) / Six‑sigma proficiency.
Experience in a clean‑room and design process for a clean‑room.
Experience in identifying relevant suppliers, composing RFQ, ordering from suppliers, supporting FAT and process equipment qualification.
Root cause analysis and risk management proficiency.
Required Knowledge, Skills, Abilities, Certifications, Licences and Affiliations   Medical device (or other highly regulated) industry production experience.
Proven experience in a manufacturing environment with manufacturing processes.
Proven experience with chemical processes, device assembly, or drug substance and drug product processes.
Ability to facilitate resolution of complex technical and operational problems.
Manage the investigation and timely resolution of issues arising from customer complaints.
Strong personal skills working in large and diverse teams, promoting inclusive and diverse discussions, and reaching alignment.
Ability to author, review and approve technical documentation for process and design…