Digital Engineer - POMS MES

stakeholder management MES Configuration quality management fit gap analysis MES Integration devops cross - functional collaboration Project Methodologies production support

• We are 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., Business & Functional 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.

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:

• 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

• 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.

Optional 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

3.73.7 out of 5 stars Albany, NY $46.23 - $72.23 an hour - Contract, Pulled from the full job description

• Health insurance
• Retirement plan
• Vision insurance
• Dental insurance, The pay range that the employer in good faith reasonably expects to pay for this position is $46.23/hour - $72.23/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.