Manufacturing Execution System Automation Lead
$94,000–$144,500 year
On-site · Malvern, Pennsylvania, United States or Spring House, Pennsylvania, United States
Job Summary
Manufacturing Execution System (MES) automation lead role based in Malvern or Spring House, PA. Lead the MES program for PAS-X across multiple sites, including deployment, configuration of interfaces, validation, qualification, and maintenance of manufacturing automation systems; participate in compliance inspections and risk assessments; drive projects, manage resources, and ensure alignment with global standards. Candidate will lead a team of MES engineers, coordinate with Quality, IT, Lab Systems, and Procurement, and promote digital technology advancements (multi-variable analysis, advanced process control, digital visualization) to transform manufacturing operations. Requires a technical degree in engineering, 6+ years MES experience, strong communication skills, knowledge of cGMP/FDA regulations, and experience with MES-automation integrations; Lean/Six Sigma experience is preferred.
Required Qualifications
- Bachelor's degree in Engineering or equivalent
- Minimum of 6 years MES experience
- Experience with PAS-X MES
- Knowledge of cGMP and FDA regulations
- Experience with validation and qualification (IQ/OQ/PQ)
- Strong written and verbal communication
- Ability to lead projects and teams
- Knowledge of OSI PI Historian
- Experience with integration between MES and automation systems
- Experience in GxP regulated environment
- Quality/compliance mindset
- Lean/Six Sigma training or certification (preferred)
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