GTO LCM Principal Process Engineer, Amsterdam

Overview

The Principal Process Engineer 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 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. The incumbent of this position explores and manages technical innovation needed to develop processes for the manufacture of medical devices. The position translates abstract project concepts or requirements into meaningful, actionable deliverables and plans.Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson&Johnson procedures and guidelines, acts as the technical lead to manage multiple small to large scale, complex projects. Coordinates and leads the utilization of internal/external resources to achieve project goals. Support external manufacturers by managing the qualification of supplier products and processes, analyzing and resolving supplier technical issues, and providing leadership as a team leader and within teams.Initiate and manage process excellence projects to improve quality, yields and value from the supply base. Represent both the supplier’s quality system and the J&J Franchise quality system; collaborate with Franchise Supplier Quality partners to ensure technical plans adhere to requirements in both systems. Partner with the New Product Development community to provide technology assessment and supplier technical support, support new product development and other product lifecycle activities, design and oversee experiments, apply statistical analyses, and prepare technical reports.Lead cross-functional teams in critical, complex projects with major impact on business unit sales and profitability; support Operations Management in leading tactical activities sustaining corporate initiatives and/or departmental objectives; participate in technology and development of partnerships to develop internal competencies for supporting external product development.Communicate business-related issues or opportunities to the next management level. Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that resources needed to do so are available and in good condition. Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.Demonstrate independent understanding and application of core GMP fundamentals, including Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs). Perform other duties as assigned as needed. Required Experience and Education

Minimum of bachelor’s degree and/or equivalent University degree required; focused degree in Engineering or Science related field preferred; Masters Preferred. A minimum of 6-8 years of relevant professional work experience.>5 years' experience in process engineering (product development, process development, scale-ups, Cost Improvement Projects, complex process issue resolution, CAPA management, Change control management, process qualification)– Advantage. Good basis in engineering principles related to processes of medical devices or pharmaceutical products – Advantage.Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

Medical Device (or other highly regulated) industry production experience. Experience in New Product Development (NPD) is preferred. Demonstrated ability in leadership and project management. Ability to oversee the development of others in the department, define complex issues and execute work that involves complex problems.Ability to influence others to achieve business objectives and excellent written and oral communication skills. Strong technical writing skills, ability to manage multiple projects simultaneously, and ability to adapt priorities based on business need. Technical support to Manufacturing Business Units for complex process issues requiring high-level technical expertise.Demonstrated success in developing and leading technical and/or business challenges; ability to lead a cross-functional/multi-discipline team. Understanding of healthcare regulated industry Quality Systems and Change Control procedures (preferred). Six Sigma/Process Excellence and/or Design Excellence experience (preferred).Ability to manage costs and budgets; prioritize multiple commitments and adapt to changing department/facility needs. Preferred skills include Agile decision making, coaching, CAPA, crisis management, critical thinking, Lean, and other related competencies.

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