GTO LCM Senior Process Engineer

The Process Engineer, Global Technical Operations /Life Cycle Management (GTO/ LCM), is 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.

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, initiate 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 University degree required, focused degree in Engineering or Science related field preferred. Masters Preferred.
• A minimum of five (5) of relevant professional work experience
• At least 3 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 statistical analysis of data – e.g. experience with Minitab tool (or equivalent)- Advantage.
• Good basis in Engineering Principles related process of medical devices or pharmaceuticals products- Advantage.
• o Full proficiency in MS Office applications (including MS project) – Advantage.
• Design of experiment (DoE)/ Six-sigma proficiency- Advantage.
• Experience in working in a clean room and design process for a clean room- Advantage.
• Experience in identifying relevant suppliers, composing RFQ, ordering from suppliers, support 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 is preferred. Proven experience with Chemical Processes, Device Assembly, or Drug Substance and Drug Product processes is preferred.
• 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 team, promoting inclusive and diverse discussions, and reaching alignment.
• Ability to author, review and approve technical documentation for process and design validations to verify compliance with technical specifications and standards.
• Ability to communicate with internal and external partners to coordinate and execute project plans.
• Ability to manage tasks according to projected scopes including compliance and quality improvement, cost reduction, cycle time reduction, capacity increase, raw material qualification, and launch preparation.
• Ability to monitor smooth execution of plans and programs through different levels of complexity, including allocation of proper level of resources to facilitate attainment of project goals within established timelines and budgets.
• Ability to ensure company 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 any other technical change required.
• Medical Device, Pharmaceutical and/or Biologics experience or other regulated industry
• Ability to ensure company compliance with government and company regulations, policies and procedures for health, safety, and environmental compliance.
• 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, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing