Job opportunity - Digital Engineer - POMS MES/100% Remote

IFLOWSOFT Solutions Inc.; Deutschland; Remote; EUR 85.000 - 110.000; Vollzeit

Zusammenfassung

Clinical research technology Company. is seeking a Digital Engineer - POMS MES to work remotely with global pharmaceutical operations. The role requires deep MES expertise, regulatory awareness, and the ability to bridge business needs with IT and validation teams across sites.

The candidate will configure MES workflows, EBRs, and recipes, support integrations with ERP/LIMS/SCADA, and lead validation and release activities in a GxP environment.

Qualifikationen

• Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or related field.
• 8-12 years of Life Sciences/Pharma manufacturing experience.
• 5 years hands-on experience with POMS MES.

Aufgaben

• Collaborate with Manufacturing, Quality, Validation, and IT to gather and document requirements.
• Translate requirements into MES specifications and designs.
• Lead workshops, discovery, fit-gap analysis and UAT.
• Optimize production workflows using POMS MES to improve performance.
• Align MES with regulatory requirements and business objectives.
• Support CSV validation activities and lifecycle documentation.

Kenntnisse

POMS MES

GxP experience

CSV validation

Troubleshooting

Documentation review

Regulatory compliance

ERP/LIMS/SCADA integrations

ISA-95

Agile / Hybrid delivery

Root cause analysis

Ausbildung

Bachelor's degree

Tools

ERP

LIMS

Historians

SCADA

Automation platforms

Jobbeschreibung

Client: Clinical research technology Company.

Title: 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.

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:
• 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