SME - MES & Manufacturing IT Operation

We are seeking a seasoned professional with 10+ years of experience in the pharmaceutical industry, including technical and functional expertise in MES, L2 and other manufacturing systems. The Senior SME will act as the enterprise-level technical authority for MES and Level 2 integrations across pharmaceutical manufacturing sites.

Requirements

• 10+ years of experience in MES implementation and support within pharmaceutical manufacturing environments.
• Deep hands-on expertise with Werum PAS-X MES, including architecture, configuration, and master data governance.
• Extensive L2 integration experience with PLC, SCADA, and DCS systems for shop-floor automation.
• Proven track record of owning validated GMP systems and ensuring compliance with GAMP 5, 21 CFR Part 11, and ALCOA+ principles.
• Leadership in technical governance for MES upgrades, patches, and performance optimization.
• Audit readiness and representation during regulatory inspections and internal audits.
• Strong validation experience, including URS, FRS, DDS, IQ, OQ, and PQ documentation and execution.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance