GTO LCM Senior Process Engineer, Amsterdam

Overview

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. They 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, and lead related activities for designated commodities. The role provides technical leadership, project management and mentoring to junior engineers and team members. They 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.Key Responsibilities

End-to-End technical support for medical device process development and validation for clinical articles and commercial manufacturing lines. Lead process characterization activities. Own process risk management, performance, and capability. Drive continuous optimization 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. Act as the technical lead for managing multiple small to large scale projects and coordinate/lead the utilization of internal/external resources to achieve project goals. Support external manufacturers through managing the qualification of supplier products and processes, analyzing and resolving supplier technical issues, and providing leadership and coaching as a team leader.Initiate and manage 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; design and oversee experiments, apply statistical analyses to evaluate results and prepare technical reports. Lead cross-functional teams in critical projects with major impact on business unit sales and profitability; support Operations Management in sustaining corporate initiatives and/or departmental objectives; participate in partnerships to develop internal competencies for supporting external product development.Communicate business-related issues or opportunities to the next management level. Execute Process Engineering activities in a GMP environment for Ethizia manufacturing assigned area. Scope, analyze data, report studies, and investigate deviations in collaboration with cross-organizational functions, R&D, QA, RA, and SC/Ex Ops for established and emerging processes at internal or external manufacturers. Adhere to all Company guidelines related to Health, Safety and Environmental practices; perform other duties as needed. Experience and Education

Qualifications

Minimum of a bachelor’s degree and/or equivalent University degree required, focused degree in Engineering or Science related field preferred. Masters preferred. A minimum of five (5) years of relevant professional work experience. At least 3 years of experience in process engineering (product development, process development, scale-ups, CIP projects, complex process issue resolution, CAPA management, Change control management, process qualification) – Advantage. Good basis in statistical analysis of data (e.g., experience with Minitab or equivalent) – Advantage. Good basis in engineering principles relatedto medical devices or pharmaceutical products – Advantage. Proficiency in MS Office applications (including MS Project) – Advantage. DoE/Six-Sigma proficiency – Advantage. Experience in working in a clean room and designing processes for a clean room – Advantage. Experience identifying relevant suppliers, composing RFQs, ordering from suppliers, supporting FAT and process equipment qualification as subject matter expert – Advantage. Root Cause Analysis and Risk Management proficiency – Advantage.REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS Medical Device (or other highly regulated) industry production experience. Proven experience in a manufacturing environment with manufacturing processes; experience with chemical processes, device assembly, or drug substance/product processes is preferred.Ability to facilitate resolution of complex technical and operational problems and manage investigations and timely resolutions of issues arising from customer complaints. Strong collaboration skills within large and diverse teams and ability to promote inclusive discussions and alignment. Ability to author, review and approve technical documentation for process and design validations to verify compliance with specifications and standards.Ability to communicate with internal and external partners to coordinate and execute project plans. Ability to manage tasks toward projected scopes including compliance and quality improvement, cost reduction, cycle time reduction, capacity increase, raw material qualification, and launch preparation.Ability to monitor and ensure smooth execution of plans and programs across varying levels of complexity, including resource allocation to attain project goals within timelines and budgets. Ability to ensure compliance with government and company regulations, policies and procedures for health, safety, and environmental compliance.Ability to engage cross-functional project teams to facilitate the transfer of new production processes and execute implementation activities to support product launch. Ability to identify and facilitate implementation of product or process improvement projects or technical changes as required. Experience in Medical Device, Pharmaceutical and/or Biologics sectors or other regulated industries.Familiarity with technical documentation control and retention. Preferred Skills:

Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, STEM applications, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing

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