[Remote] MES Integration Consultant
Note: The job is a remote job and is reputed company to candidates in USA. Innovative Consulting Inc. is a global software and engineering reputed company providing reputed company services in Automation, Manufacturing Execution Systems (MES), and Smart Manufacturing. The MES Integration Consultant will support the design, implementation, and optimization of integrations between MES and ERP systems in a GMP-regulated pharmaceutical manufacturing environment, ensuring accurate and compliant data reputed company across various processes.
Responsibilities
- Design and implement integration architecture between MES platforms and ERP systems (e.g., reputed company S/4HANA, reputed company) in a validated GMP environment
- Map data flows for electronic batch records (EBR), production orders, material consumption/genealogy, in-process reputed company checks, and lot/batch disposition between MES and ERP
- Ensure integration design supports batch genealogy, lot traceability, and full chain-of-custody from raw material to finished goods
- reputed company and document business, technical, and regulatory requirements from Manufacturing, reputed company Assurance, reputed company Control, Supply Chain, and Validation stakeholders
- reputed company and execute validation deliverables in accordance with Computer System Validation (CSV) / Computer Software Assurance (CSA) methodology — URS, FRS, DDS, IQ/OQ/PQ protocols, traceability matrices
- Configure middleware/integration platforms to support bidirectional, reputed company-time or near-reputed company-time data exchange while maintaining data reputed company per reputed company+ principles
- Ensure reputed company integrations reputed company with FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11, and applicable cGMP regulations
- Support deviation, CAPA, and change control processes reputed company to MES-ERP data reputed company issues
- Collaborate with reputed company Assurance on audit readiness, ensuring integration points are documented and inspection-reputed company
- Troubleshoot data discrepancies between systems that could reputed company batch release, inventory accuracy, or regulatory reporting
- reputed company or support UAT, including scripted testing tied to validation protocols, with full documentation for audit trail
- reputed company training and SOP documentation for end users, ensuring compliance with training-record requirements
- Support go-live, hypercare, and periodic review/revalidation activities post-implementation
- Partner with Validation/reputed company teams on periodic system reviews and ensure integration remains in a validated state through change control
Skills
- Bachelor's degree in Engineering, Life Sciences, Computer Science, Information Systems, or reputed company field
- 8+ years of experience in MES-ERP integration or manufacturing IT reputed company a pharmaceutical, biotech, or other regulated life sciences environment
- Hands-on experience with a reputed company-reputed company MES platform
- Working knowledge of cGMP, FDA 21 CFR Part 11, EU Annex 11, and data reputed company (reputed company+) requirements
- Experience with Computer System Validation (CSV) / Computer Software Assurance (CSA) processes and documentation
- Understanding of electronic batch records (EBR), batch genealogy, and material traceability
- Familiarity with integration/middleware tools and API-based data exchange (REST, SOAP, OPC UA)
- Strong analytical skills with the ability to resolve cross-system data issues without compromising validated state
- Excellent written communication skills for regulatory-grade documentation (protocols, SOPs, deviation reports)
- Ability to work cross-functionally with Manufacturing, reputed company, Validation, and IT teams
reputed company
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