GTO LCM Senior Process Engineer

Job Information   Job Function:  Supply Chain Engineering
Job Sub Function:  Process Engineering
Job Category:  Scientific/Technology
All Job Posting Locations:  Nijmegen, Netherlands

Job Description:

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 complex production and processing equipment. He/she will manage and maintain the technical qualification of External Manufacturers and their (technical) processes, supervise or aid in the resolution of medium to complex 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, project management and mentoring to junior engineers and team members. He/she will manage and maintain 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 as the Subject Matter Expert.
DUTIES & RESPONSIBILITIES  In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position is accountable for:

Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
End-to-End technical support for medical device process development and validation for clinical articles and commercial manufacturing lines.
Leads process characterization activities
Owns process risk management, performance, and capability
Drives continuous optimization to sustain a healthy technology roadmap for the ETHIZIA manufacturing process
Owns scale-up, validation remediation, and capacity upscaling at the Nijmegen site
Acts as liaison for process development collaborating with R&D and DQE.
Acts as the technical lead to managing multiple small to large scale projects and coordinates and leads to the utilization of internal/external resources to achieve project goals. The position will support external manufacturers through managing the qualification of supplier products and processes, analyzing and resolving supplier technical issues, providing leadership and coaching as a team leader and within teams, initiates and manages projects to improve quality, yields and value received from the supply base.
Partner with the R&D and QDE communities to provide technology assessment and supplier technical support, supporting new product development and other product lifecycle activities, designing and overseeing experiments, applying statistical analyses to evaluate results and preparing 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 and/or departmental objectives and participate in technology and development of partnerships to develop internal competencies for supporting external product development.
Responsible for communicating business related issues or opportunities to next management level
Process Engineering technical in a GMP environment for Ethizia manufacturing assigned area
Responsible for Technical Efforts involving scoping and executing, data analysis and collection as well as reporting of studies and investigating deviations in collaboration with cross-organizational functions, R&D, QA, RA, SC/Ex Ops for established and emerging processes at Internal or External Manufacturers.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Performs other duties assigned as needed
EXPERIENCE AND EDUCATION
Qualifications
Minimum of bachelor’s degree and/or equivalent…