ICONMA · 7 hours ago
Sr. Analyst – II
United States
Full-time
Remote
Mid, Senior Level
4+ years expICONMA is a company that provides staffing and consulting services, and they are seeking a Sr. Analyst – II for their client in the biopharmaceutical sector. The role involves implementing and configuring MES systems, providing support for manufacturing operations, and ensuring compliance with regulatory standards.
Staffing & Recruiting
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, data integrity (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
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
Benefits
Health Benefits
Referral Program
Excellent growth and advancement opportunities
Company
ICONMA
ICONMA: Your Partner in Global Staffing Solutions and Digital Transformation ICONMA is a globally recognized, Woman-Owned staff augmentation and technology consulting firm.
1001-5000 employees
H1B Sponsorship
ICONMA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (31)
2023 (26)
2022 (39)
2021 (37)
2020 (69)
Funding
Current Stage
Late StageLeadership Team
Claudine George
Founder and CEO of ICONMA, LLC
Company data provided by crunchbase