Sr. Manufacturing Engineer, E2e Delivery

Johnson & Johnson Johnson & Johnson · Pharma · Raynham, MA +1

This role is for a Sr. Manufacturing Engineer in the Orthopaedics business at Johnson & Johnson. The engineer will lead projects, provide technical support for manufacturing processes, manage equipment qualification, and ensure compliance with regulatory requirements. The role involves new product introduction, process improvement, and capacity expansion within a regulated healthcare manufacturing environment.

What you'd actually do

  1. Responsible for leading projects within Raynham site, representing the site on various forums. Develop and maintain detailed Microsoft project plans for impacted product families. Provides direction in supporting the needs of manufacturing areas in terms of meeting the requirements for quality standards, compliant documentation, capacity and product availability.
  2. Provides technical support in the development and implementation of manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation.
  3. Support updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system.
  4. Lead and implement activities required to transition equipment from installation through IQ. OQ, and PQ phase.
  5. Perform hands-on equipment assessments, testing, and qualification activities

Skills

Required

  • Manufacturing background
  • New product introduction (NPI)
  • Manufacturing process improvement
  • Capacity expansions
  • Site optimization
  • Excellent communication skills
  • Ability to work with a multi-functional team
  • Technical support
  • Process studies
  • Root cause analysis
  • Problem solving
  • Equipment qualification (IQ, OQ, PQ)
  • Controlled documentation creation (SOPs, work instructions, specifications)
  • Capital justifications
  • Cost-benefit analysis
  • Supply Network programs
  • New asset purchasing and commissioning
  • Validation strategy
  • Validation document authoring
  • Statistical analysis
  • Technical writing

Nice to have

  • Direct experience in a medium to large scale manufacturing companies

What the JD emphasized

  • Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects.