POMS MES Techno-Functional SME

This is a fully remote position, open to applicants in New York.

📋 Description

• Collaborate with stakeholders from Manufacturing, Quality, Validation, and IT to gather, analyze, and document business requirements.

• Convert business requirements into functional specifications, solution designs, and strategies for implementation within the MES.

• Facilitate workshops for requirements gathering, discovery sessions, fit-gap analyses, design reviews, and user acceptance testing.

• Enhance production workflows and utilize POMS MES capabilities to elevate operational performance.

• Ensure MES solutions are aligned with manufacturing processes, business goals, and regulatory standards.

• Aid in the harmonization of processes across various manufacturing sites.

• Configure, support, and improve POMS MES workflows, electronic batch records, recipes, and manufacturing execution processes.

• Diagnose issues within MES modules and resolve production support challenges through root cause analysis and corrective measures.

• Oversee and evaluate MES integrations with ERP, LIMS, Historians, Automation/SCADA, and other manufacturing applications.

• Assess technical specifications, configuration documents, and implementation deliverables.

• Assist with system deployments, upgrades, migrations, and release management processes.

• Provide expertise in executing electronic batch records, managing deviations, conducting manufacturing investigations, and handling exceptions.

• Support Computer System Validation activities throughout the entire system lifecycle.

• Author, review, and manage validation documentation, including URS, FRS, DS, IQ, OQ, PQ, and VSR.

• Ensure adherence to FDA 21 CFR Part 11, GAMP 5, and GMP guidelines.

⛳️ Requirements

• Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related discipline.

• 8–12 years of experience in Life Sciences, Pharmaceutical, or Biotech manufacturing settings.

• Over 5 years of hands-on experience with supporting or implementing POMS MES solutions.

• Strong comprehension of MES concepts, electronic batch records, batch execution, manufacturing operations, and production workflows.

• Experience in GxP-regulated environments is essential.

• In-depth knowledge of pharmaceutical manufacturing processes, validation methodologies, and quality systems.

• Experience in supporting MES implementations, enhancements, upgrades, and production support initiatives.

• Capability to review and interpret both functional and technical documentation.

• Strong troubleshooting skills and analytical problem-solving abilities.

• Preferred: experience with large-scale MES implementation or site rollout initiatives.

• Preferred: familiarity with ERP, LIMS, Historian, SCADA, or automation platform integrations.

• Preferred: understanding of ISA-95 manufacturing standards and digital manufacturing architectures.

• Preferred: experience in supporting global manufacturing organizations.

🏝️ Benefits

• Variable incentives, bonuses, or commissions may be provided based on the position and applicable regulations.

• Paid time off includes vacation (12–25 days depending on grade), company holidays, personal days, and sick leave.

• Comprehensive medical, dental, and vision insurance coverage.

• Retirement savings plans (e.g., 401(k) in the U.S.).

• Life and disability insurance coverage.

• Access to employee assistance programs.

• Additional benefits as provided by local policies and eligibility criteria.