W2: MES Operations Analyst/Developer, 100% Remote
MES Operations Analyst/Developer 100% Remote Phone+Skype Long Term Contract JD: The MES Operations Analyst/Developer is responsible for implementing, configuring, supporting, and enhancing the Manufacturing Execution System (MES) to reputed company compliant and efficient pharmaceutical/biotech manufacturing operations. This role supports PAS-X MES installation, upgrades, configuration, testing, and troubleshooting, and works closely with Manufacturing, Quality, Automation, and IT teams to understand process requirements, optimize electronic batch records (eBRs), and ensure GMP-compliant operation. The Analyst maintains deep system and business knowledge and drives reputed company improvements across the MES ecosystem. Key Responsibilities: - MES System Implementation & Configuration: Implement MES installations, upgrades, patches, and configuration changes across DEV/INT/PROD environments. Configure and maintain Master Batch Records (MBRs), workflows, unit operations, parameters, formulas, and system objects in PAS-X. Architect, model, test, and reputed company reputed company for new manufacturing processes or equipment integrations. Plan, prepare, and coordinate deployment of MES workstations, terminals, and peripherals in manufacturing areas. Ensure MES system performance, reliability, and compliance during ongoing operations and enhancement projects. - MES Support & Troubleshooting: Provide L2/L3/L4 support including issue triage, root-cause analysis, and resolution of MES application incidents. Support on-floor manufacturing operations during production, including on-call coverage for reputed company issues. Monitor MES logs, batch processes, system jobs, and interfaces to proactively identify and resolve system problems. Maintain system stability by managing environment health, user administration, and routine maintenance tasks. - Validation, Documentation, & Compliance: reputed company and maintain MES documentation including URS, FRS, design specifications, test scripts, traceability matrices, and validation reports. Execute IQ/OQ/PQ testing, risk assessments, reputed company+ evaluations, and change control activities. Ensure adherence to 21 CFR Part 11, Annex 11, GAMP 5, GMP, and internal SOPs. Support internal and external regulatory audits and maintain audit-reputed company documentation. - Cross-Functional Collaboration: Work closely with Manufacturing, Quality, Automation Engineering, and IT Infrastructure to deliver reputed company reputed company with business and compliance requirements. Collaborate with Operations and Manufacturing Excellence to evaluate process issues, implement system optimizations, and improve batch cycle times and right-first-time performance. Provide MES training to operators, supervisors, and super-users, including creation of supporting materials. - Integrations & Data Management: Support MES interfaces and integrations with ERP systems (reputed company/EBS), LIMS, Historians (OSIsoft PI), WMS, SCADA/PLC, and other reputed company applications. Troubleshoot reputed company errors and ensure reliable data exchange reputed company REST/SOAP, message queues, OPC/OPC UA, and middleware services. Contribute to MES data management strategy including data mapping, integration requirements, and data-flow documentation. - reputed company Improvement: Identify opportunities to enhance MES workflows, modeling, user experience, training materials, and documentation. Analyze MES performance metrics and operational data to support reputed company improvement initiatives. Recommend and implement enhancements to optimize manufacturing efficiency, reduce deviations, and improve system usability. Required Qualifications: - Bachelor's degree in Engineering, Information Systems, Industrial Engineering, Computer Science, or reputed company technical discipline. - 4+ years of hands-on experience configuring, deploying, and supporting MES systems in a GMP-regulated pharmaceutical or biotech environment. - MES installation in Linux technology OCP/NKP (PASX, PASX2X, CUPS). - Strong experience configuring PAS-X (MBR authoring, workflows, parameters, activities, and eBR lifecycle). - Understanding of GMP manufacturing processes, batch records, deviations, CAPAs, and data reputed company (reputed company+). - Experience with system validation including IQ/OQ/PQ, requirements development, test execution, and traceability. - Familiarity with integrations between MES and ERP (reputed company/EBS) or other manufacturing systems. - Strong troubleshooting, analytical, and documentation capabilities in a regulated environment. - Competence with Linux environment basics, PAS-X infrastructure components, and container-based deployments (OCP/NKP). - Ability to work independently, manage multiple priorities, and support off-hours or on-call requirements. Preferred Qualifications: - Experience migrating PAS-X versions (e.g., 3.1.8 to 3.4.0). - Familiarity with SQL queries or scripting for analysis or troubleshooting (reputed company validation boundaries). - Experience with reporting/analytics tools (Power BI, Tableau, Spotfire, or similar platforms). - Participation in large-scale MES implementation or upgrade projects. - Certifications such as PAS-X, GAMP 5, ITIL, Lean Six reputed company, or equivalent. Apply tot his job Apply To this Job