Client: Clinical research technology Company.
Title: Digital Engineer - POMS MES
Location: Remote
Overview
Client is seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment.
The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.
This role requires a combination of strong functional knowledge of pharmaceutical manufacturing processes, hands-on POMS MES expertise, and familiarity with CSV validation and regulatory compliance requirements.
Key Responsibilities:
Collaborate with Manufacturing, Quality, Validation, and IT stakeholders to gather, analyze, and document business requirements.
Translate business requirements into MES functional specifications, solution designs, and implementation strategies.
Lead requirements workshops, discovery sessions, fit-gap analysis, design reviews, and user acceptance testing (UAT).
Partner with manufacturing teams to optimize production workflows and leverage POMS MES capabilities to improve operational performance.
Drive alignment between MES solutions, manufacturing processes, business objectives, and regulatory requirements.
Support process harmonization initiatives across manufacturing sites.
MES Technical Responsibilities
Configure, support, and enhance POMS MES workflows, electronic batch records (EBR), recipes, and manufacturing execution processes.
Support MES module configuration, troubleshooting, and issue resolution activities.
Perform root cause analysis and corrective actions for production support issues.
Support and review MES integrations with enterprise systems such as ERP, LIMS, Historians, Automation/SCADA, and other manufacturing applications.
Review technical specifications, configuration documentation, and implementation deliverables.
Assist with system deployments, upgrades, migrations, and release management activities.
Provide expertise in electronic batch record execution, deviations management, manufacturing investigations, and exception handling.
Validation & Compliance Responsibilities
Support Computer System Validation (CSV) activities throughout the system lifecycle.
Author, review, and maintain validation documentation including:
o User Requirements Specifications (URS)
o Functional Requirements Specifications (FRS)
o Design Specifications (DS)
o Installation Qualification (IQ)
o Operational Qualification (OQ)
o Performance Qualification (PQ)
o Traceability Matrices
o Validation Summary Reports (VSR)
Ensure compliance with:
o FDA 21 CFR Part 11
o GAMP 5 Guidelines
o Good Manufacturing Practices (GMP)
o ALCOA+ and Data Integrity requirements
o Corporate Quality Management System procedures
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Mandatory skills:
Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related field.
8 12 years of experience in Life Sciences, Pharmaceutical, or Biotech manufacturing environments.
5+ years of hands-on experience supporting or implementing POMS MES solutions.
Strong understanding of MES concepts, electronic batch records (EBR), batch execution, manufacturing operations, and production workflows.
Experience working in GxP-regulated environments.
Solid understanding of pharmaceutical manufacturing processes, validation methodologies, and quality systems.
Experience supporting MES implementations, enhancements, upgrades, and production support activities.
Ability to review and interpret functional and technical documentation.
Strong troubleshooting and analytical problem-solving skills.
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Desirable skills:
Experience with large-scale MES implementation or site rollout programs.
Exposure to system integrations involving ERP, LIMS, Historian, SCADA, or automation platforms.
Knowledge of ISA-95 manufacturing standards and digital manufacturing architectures.
Experience supporting global manufacturing organizations.
Familiarity with Agile and hybrid project delivery methodologies
