Pharma MES Techno-Functional SME — Compliance & Validation

PDDN INC.; Chicago (IL); Remote; USD 120,000 - 160,000; Full time

Job summary

PDDN INC. is seeking a POMS MES Techno-Functional SME to bridge business, quality, validation, and IT in pharma manufacturing and to configure, support, and implement MES solutions ensuring compliance and operational excellence.

The role focuses on GxP compliance, troubleshooting, and thorough documentation to maintain FDA and GMP standards in a fast-paced manufacturing environment in Chicago, IL.

Qualifications

• Must-have: troubleshooting, documentation, and regulatory compliance (FDA 21 CFR Part 11; GAMP 5).

Responsibilities

• Bridge business, quality, validation, and IT to configure, support, and implement MES solutions within pharma manufacturing.
• Ensure compliance and operational excellence across GxP environments.

Skills

Troubleshooting

Documentation

Regulatory Compliance (FDA 21 CFR Part

Tools

POMS MES

Job description

PDDN INC. is seeking a POMS MES Techno-Functional SME to bridge business, quality, validation, and IT in pharma manufacturing and to configure, support, and implement MES solutions ensuring compliance and operational excellence.

The role focuses on GxP compliance, troubleshooting, and thorough documentation to maintain FDA and GMP standards in a fast-paced manufacturing environment in Chicago, IL.