Digital Engineer - POMS MES

IFLOWSOFT Solutions Inc.; Deutschland; Remote; EUR 90.000 - 150.000; Vollzeit

Zusammenfassung

Iflowsoft Solutions inc is seeking an experienced Digital Engineer - POMS MES SME to guide the configuration, validation, and deployment of MES solutions across pharmaceutical manufacturing sites. The role focuses on translating business needs into MES specifications while ensuring alignment with regulatory requirements and GxP standards.

The candidate will collaborate with manufacturing, quality, validation and IT teams, drive UAT and design reviews, and support system deployments, upgrades,

Qualifikationen

• Bachelor's degree or higher in engineering, CS, IT, life sciences, or related field.
• 5+ years with POMS MES or equivalent MES experience in Life Sciences.
• Exposure to CSV validation and regulatory compliance requirements.

Aufgaben

• Collaborate with Manufacturing, Quality, Validation and IT to gather business requirements.
• Translate requirements into MES functional specs, designs and implementation plans.
• Lead workshops, fit-gap analyses, design reviews and UAT.
• Optimize production workflows using POMS MES to improve operations.
• Coordinate MES integrations with ERP, LIMS, Historians, SCADA and other systems.
• Support CSV activities, validation docs, and regulatory compliance.

Kenntnisse

MES concepts

Troubleshooting

Analytical thinking

Regulatory compliance understanding

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or related field

Tools

POMS MES

Jobbeschreibung

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.
• 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

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.

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

Iflowsoft Solutions inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. We promote and support a diverse workforce at all levels in the company. This is not an unsolicited mail and if it is not intended for you or you are not interested in receiving our e-mails, you may unsubscribe