POMS MES Techno-Functional SME

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

📋 Description

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

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

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

• Collaborate with manufacturing teams to enhance production workflows and utilize POMS MES capabilities effectively.

• Ensure alignment among MES solutions, manufacturing processes, business objectives, and regulatory standards.

• Assist in process harmonization initiatives across various manufacturing sites.

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

• Provide support for MES module configuration, troubleshooting, and resolution of issues.

• Conduct root cause analysis and implement corrective actions for production support challenges.

• Assist in and review MES integrations with ERP, LIMS, Historians, Automation/SCADA, and other manufacturing applications.

• Evaluate technical specifications, configuration documentation, and implementation deliverables.

• Aid in system deployments, upgrades, migrations, and release management activities.

• Offer expertise in electronic batch record execution, deviation management, manufacturing investigations, and exception handling.

• Contribute to Computer System Validation activities throughout the system lifecycle.

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

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

⛳️ 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 direct experience supporting or implementing POMS MES solutions.

• In-depth understanding of MES concepts, electronic batch records (EBR), batch execution, manufacturing operations, and production workflows.

• Experience in GxP-regulated environments.

• Strong comprehension of pharmaceutical manufacturing processes, validation methods, and quality systems.

• Background in supporting MES implementations, enhancements, upgrades, and production support tasks.

• Proficient in reviewing and interpreting functional and technical documentation.

• Excellent troubleshooting and analytical problem-solving abilities.

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

• Familiarity with ERP, LIMS, Historian, SCADA, or automation platform integrations is advantageous.

• Knowledge of ISA-95 manufacturing standards and digital manufacturing architectures is preferred.

• Experience supporting global manufacturing organizations is a plus.

🏝️ Benefits

• Vacation: 12-25 days, based on grade.

• Company-paid holidays.

• Personal Days.

• Sick Leave.

• Medical, dental, and vision coverage (or coordination with provincial healthcare in Canada).

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

• Life and disability insurance.

• Employee assistance programs.

• Additional benefits as per local policy and eligibility.

• Variable incentives, bonuses, or commissions may be available depending on the position and applicable laws.

• Reasonable accommodations during the recruitment process.