Manufacturing Execution System Automation Lead

Johnson & Johnson Johnson & Johnson · Pharma · Malvern, PA +1

Lead the Manufacturing Execution System (MES) Automation team, focusing on implementation, validation, and maintenance of ISA-95 level 1 and 2 manufacturing automated systems and level 3 recipe content. The role involves supporting PAS-X MES, configuring interfaces, ensuring compliance with cG(a)MP, leading projects, and transforming sites with new digital technologies. Requires experience in MES, GxP regulated environments, and strong problem-solving skills.

What you'd actually do

  1. Support the PAS-X manufacturing execution system (MES), configure interfaces, ensure compliance with global standards, write and perform validation protocols, participate in compliance inspections, hold and support risk assessments, and support investigations.
  2. Define project scope and ensure resources, capabilities and processes are in place.
  3. Act as project leader/core team member by tracking cost, quality, and schedule to ensure an effective management of project execution.
  4. Ensure programs stay on target through accurate resourcing and removing obstacles, which may involve communication at a senior level within the business.
  5. Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others and develop new partnerships to optimize processes.

Skills

Required

  • PAS-X Manufacturing Execution System (MES)
  • GxP regulated environment
  • Bachelor's degree in Engineering or equivalent
  • 6 years of MES relevant experience
  • Excellent written and verbal communication skills
  • Strong decision making and problem-solving skills
  • Strategic thinking
  • Change leadership

Nice to have

  • cGMP and FDA regulations knowledge
  • Process Excellence tools (Lean, Six Sigma)
  • OSI PI historian knowledge
  • MES and automation systems integration knowledge
  • Technology development and validation knowledge
  • Design of experiments
  • Statistical analysis

What the JD emphasized

  • PAS-X Manufacturing Execution System (MES)
  • GxP regulated environment
  • cGMP
  • validation