GTO LCM Principal Process Engineer

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.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Acts as the technical lead to manage multiple small to large scale, complex projects and coordinates and leads 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, provide leadership and coaching as a team leader and within teams, initiate and manage process excellence projects to improve quality, yields and value received from the supply base.
• Act as the representative for both the supplier’s quality system and the J&J Franchise quality system and will need to work with Franchise Supplier Quality partners to ensure that technical plans adhere to requirements in both systems.
• Partner with the New Product Development community 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, complex 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
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
• Responsible for ensuring 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 but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Performs other duties 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 (CIPs), complex process issue(s) resolution, CAPA management, Change control management, process qualification- Advantage.
• Good basis in Engineering Principles related process of medical devices or pharmaceuticals products- Advantage.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.

• Medical Device (or other highly regulated) industry production experience.
• Experience in NPD (New Product Development) 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, the ability to manage multiple projects simultaneously and the ability to fluently change priorities based upon business need.
• Technical support to Manufacturing Business Units for complex process issues, where higher level of technical expertise in each field of knowledge is required.
• Must have demonstrated successful completion of developing and leading several technical and/or business challenges. Demonstrated ability to lead a cross-functional/multi discipline team is required.
• Demonstrated understanding of the healthcare regulated industry Quality Systems and Change Control procedures is preferred.
• Six Sigma/Process Excellence and/or Design Excellence experience is preferred.
• Position will be required to manage costs and budgets.
• Ability to prioritize multiple commitments and technical problem-solving duties.
• Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches.

Preferred Skills:

Agile Decision Making, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research

Location: Nijmegen, N