Pi Lead

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

Lead PI Engineer role in Supply Chain Engineering at Johnson & Johnson, focusing on the Aveva PI system for manufacturing automation. Responsibilities include configuring interfaces, ensuring compliance with cG(a)MP, leading projects, developing global standards, and transforming the site with digital technology. Requires a Bachelor's degree in engineering and 6+ years of experience in a GxP regulated environment, with specific experience in Aveva PI.

What you'd actually do

  1. Support the Aveva PI system, 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. Lead PI Engineer
  3. Lead a team of internal and external PI engineers.
  4. Manage and lead a large program of projects.
  5. Implement or lead execution system code change, perform or lead validation, ensure that site and global standards are met, lead risk assessments, lead GMP audits as team representative.

Skills

Required

  • Aveva PI
  • written and verbal communication skills
  • decision making and problem-solving skills
  • strategically think and lead change
  • GxP regulated environment
  • Bachelor's degree in Engineering

Nice to have

  • cGMPs and FDA regulations
  • Process Excellence tools (Lean, Six Sigma)
  • integration between MES and automation systems
  • technology development and validation
  • design of experiments and statistical analysis

What the JD emphasized

  • Experience in GxP regulated environment and a related position is required