Gto Lcm Principal Process Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Nijmegen, Netherlands

This role is for a Principal Process Engineer in the healthcare industry, specifically focusing on supporting complex production and processing equipment for medical devices. The engineer will manage technical qualifications of external manufacturers, resolve complex technical issues, lead projects, and provide technical leadership and mentoring. The role involves translating project concepts into deliverables, partnering with New Product Development, and ensuring compliance with GMP, GDP, and quality systems. Experience in process engineering, medical device production, and project management is required.

What you'd actually do

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Demonstrate independent understanding and application of core GMP fundamentals, including בתור: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).

Skills

Required

  • Bachelor's degree in Engineering or Science
  • 6-8 years of relevant professional work experience
  • 5+ years of 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)
  • Medical Device industry production experience
  • Demonstrated ability in leadership and project management
  • Ability to oversee the development of others in the department
  • Ability to define complex issues and execute work that involves complex problems
  • Ability to influence others to achieve business objectives
  • Excellent written and oral communication skills
  • Strong technical writing skills
  • Ability to manage multiple projects simultaneously
  • Ability to fluently change priorities based upon business need
  • Technical support to Manufacturing Business Units for complex process issues
  • Demonstrated successful completion of developing and leading several technical and/or business challenges
  • Demonstrated ability to lead a cross-functional/multi discipline team

Nice to have

  • Masters degree
  • Masters Preferred
  • Good basis in Engineering Principles related process of medical devices or pharmaceuticals products
  • Experience in NPD (New Product Development)

What the JD emphasized

  • Medical Device (or other highly regulated) industry production experience.
  • Demonstrated ability to lead a cross-functional/multi discipline team is required.