Management Consulting Group · 5 hours ago
GILDJP00016784 MES Operations Analyst\/Developer avail for w2 ref
Foster City, CA, United States
Full-time
Onsite
Mid Level
$100/hr - $100/hr
4+ years expManagement Consulting Group is a company in the Biotechnology industry, and they are seeking a MES Operations Analyst/Developer to enhance and support their Manufacturing Execution System (MES). The role involves implementing MES solutions, providing troubleshooting support, ensuring compliance, and collaborating with various teams to optimize manufacturing processes.
Human ResourcesRecruitingStaffing Agency
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 deploy MES solutions 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 priority 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: Develop and maintain MES documentation including URS, FRS, design specifications, test scripts, traceability matrices, and validation reports. Execute IQ/OQ/PQ testing, risk assessments, ALCOA+ 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-ready documentation
Cross-Functional Collaboration: Work closely with Manufacturing, Quality, Automation Engineering, and IT Infrastructure to deliver MES solutions aligned 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 (SAP/EBS), LIMS, Historians (OSIsoft PI), WMS, SCADA/PLC, and other enterprise applications. Troubleshoot interface errors and ensure reliable data exchange via 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
Continuous Improvement: Identify opportunities to enhance MES workflows, modeling, user experience, training materials, and documentation. Analyze MES performance metrics and operational data to support continuous improvement initiatives. Recommend and implement enhancements to optimize manufacturing efficiency, reduce deviations, and improve system usability
Qualification
Required
Bachelor's degree in Engineering, Information Systems, Industrial Engineering, Computer Science, or related 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 integrity (ALCOA+)
Experience with system validation including IQ/OQ/PQ, requirements development, test execution, and traceability
Familiarity with integrations between MES and ERP (SAP/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
Experience migrating PAS-X versions (e.g., 3.1.8 to 3.4.0)
Familiarity with SQL queries or scripting for analysis or troubleshooting (within 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 Sigma, or equivalent
Company
Management Consulting Group
Management Consulting Group is a staffing company that offers recruiting and managed services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Todd Ghanizadeh
Chief Executive Officer
Company data provided by crunchbase