CSV/MES Systems Specialist - Pennsylvania

We are seeking a professional specialized in Computer System Validation (CSV) for Manufacturing Execution Systems (MES) to support digital transformation projects in Eli Lilly pharmaceutical manufacturing facilities through the Applied Engineering Group team.

The candidate will lead the validation, implementation, and support of MES systems under strict GxP regulatory standards, ensuring data integrity and compliance within world-class manufacturing environments.

• Execute and coordinate CSV activities (IQ, OQ, PQ) for MES systems in GxP environments
• Develop validation documentation: VMP, URS, FS, DS, protocols, and reports
• Manage implementation and configuration of MES platforms (Plex, SAP ME, Rockwell Pharma Suite, or similar)
• Collaborate with QA, Manufacturing, IT, and vendors to ensure regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, GAMP 5)
• Lead Change Control, CAPA, and Deviation Management processes related to computerized systems
• Participate in regulatory inspections and internal audits as an SME for computerized systems
• Support MES integration with ERP (SAP), LIMS, DCS/SCADA, and other manufacturing systems

Do you have experience in Systems engineering?, Do you have a Bachelor’s degree?, Bachelor’s degree in Engineering (Industrial, Chemical, Electrical, Systems) or Pharmacy, Minimum of 3-5 years of CSV experience in the pharmaceutical, biotech, or life sciences industry, * Proven experience with MES systems in regulated GxP environments

• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11
• Advanced English proficiency (C1/C2) required - experience in global environments
• Strong technical communication skills and ability to work in multicultural teams
• Willingness and availability to relocate to the United States, * Project management certifications (PMP, PRINCE2) or Lean / Six Sigma
• Experience with data management systems: Veeva, TrackWise, Documentum
• Knowledge of Industry 4.0 / pharmaceutical manufacturing digitalization
• Experience in biopharmaceutical environments (biologics, injectables, sterile products)

Skills

Leadership Strategy Communications Creative Problem Solving

$50 - $75 an hour - Full-time, Contract