Remote POMS MES Digital Engineer | GMP/GxP Expert

PDDN; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

PDDN is seeking a Digital Engineer – POMS MES SME for pharma manufacturing (GxP) to bridge business, quality, validation and IT. You will configure, support and implement MES solutions to ensure regulatory compliance and operational excellence.

The role requires deep MES expertise, experience with POMS MES, EBR workflows, GMP/GxP, and CSV validation, with strong troubleshooting and documentation skills. Immediate start and potential for long-term impact in global manufacturing.

Qualifications

• 8–12 yrs Pharma/Life Sciences exp, 5+ yrs POMS MES
• Strong MES, EBR, workflows, GMP/GxP, CSV validation
• Troubleshooting, documentation, compliance (FDA 21 CFR Part 11, GAMP 5)
• Optional: Large-scale MES rollout, ERP/LIMS/SCADA integration; ISA-95, Agile/hybrid delivery, global manufacturing

Responsibilities

• Configure, support and implement MES solutions
• Ensure regulatory compliance and operational excellence
• Collaborate across business, quality, validation and IT teams

Skills

Pharma/Life Sciences

POMS MES

GMP/GxP

FDA 21 CFR Part 11

CSV Validation

Troubleshooting

Documentation

Regulatory Compliance

Job description

PDDN is seeking a Digital Engineer – POMS MES SME for pharma manufacturing (GxP) to bridge business, quality, validation and IT. You will configure, support and implement MES solutions to ensure regulatory compliance and operational excellence.

The role requires deep MES expertise, experience with POMS MES, EBR workflows, GMP/GxP, and CSV validation, with strong troubleshooting and documentation skills. Immediate start and potential for long-term impact in global manufacturing.