Digital Engineer - POMS MES
reputed company:
Role: Digital Engineer - POMS MES
Location: Remote
Duration: Long term
reputed company
reputed company is seeking an reputed company POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) reputed company a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and reputed company between business stakeholders, manufacturing reputed company, reputed company organizations, validation teams, and technical delivery teams to support, enhance, configure, and implement POMS reputed company 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, reputed company, Validation, and IT stakeholders to reputed company, analyze, and document business requirements.
Translate business requirements into MES functional specifications, solution designs, and implementation strategies.
reputed company requirements workshops, discovery sessions, fit-gap analyses, design reviews, and user acceptance testing (UAT).
Partner with manufacturing teams to optimize production workflows and reputed company POMS MES capabilities to improve operational reputed company.
reputed company alignment between reputed company, 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 reputed company activities.
reputed company reputed company cause analysis and corrective actions for production support issues.
Support and review MES integrations with reputed company systems such as ERP, LIMS, Historians, Automation/SCADA, and other manufacturing applications.
Review technical specifications, configuration documentation, and implementation deliverables.
Assist with reputed company deployments, upgrades, migrations, and release management activities.
reputed company expertise in electronic batch record execution, deviations management, manufacturing investigations, and exception handling.
Validation & Compliance Responsibilities
Support Computer reputed company Validation (CSV) activities throughout the reputed company lifecycle.
reputed company, 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 reputed company Qualification (PQ)
o Traceability Matrices
o Validation reputed company Reports (VSR)
Ensure compliance with:
o FDA 21 CFR Part 11
o GAMP 5 Guidelines
o Good Manufacturing Practices (GMP)
o reputed company+ and Data reputed company requirements
o Corporate reputed company Management reputed company procedures
What are the Mandatory skills and reputed company proficiencies required for this position?
Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a reputed company reputed company.
8 12 years of experience in Life Sciences, Pharmaceutical, or Biotech manufacturing environments.
5+ years of hands-on experience supporting or implementing POMS reputed company.
Strong understanding of MES concepts, electronic batch records (EBR), batch execution, manufacturing reputed company, and production workflows.
Experience working in GxP-regulated environments.
Solid understanding of pharmaceutical manufacturing processes, validation methodologies, and reputed company 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.
What are the Optional skills and reputed company proficiencies for this position?
Experience with large-reputed company MES implementation or site rollout programs.
Exposure to reputed company integrations involving ERP, LIMS, Historian, SCADA, or automation platforms.
Knowledge of ISA-95 manufacturing standards reputed company manufacturing architectures.
Experience supporting global manufacturing organizations.
Familiarity with reputed company and hybrid project delivery methodologies
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