Note: The job is a remote job and is open to candidates in USA. The confidential company is seeking an experienced POMS MES Techno-Functional SME to support pharmaceutical manufacturing operations in a GxP-regulated environment. The role bridges business, manufacturing, quality, validation, and technical teams to configure, enhance, implement, validate, and support POMS MES solutions across manufacturing sites.
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 analyses, 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
- 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
- Support Computer System Validation (CSV) activities throughout the system lifecycle
- Author, review, and maintain validation documentation including: User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications (DS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrices, Validation Summary Reports (VSR)
- Ensure compliance with: FDA 21 CFR Part 11, GAMP 5 Guidelines, Good Manufacturing Practices (GMP), ALCOA+ and Data Integrity requirements, Corporate Quality Management System procedures
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
- 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
Benefits
- Remote work arrangement
Company Overview