Sr. Analyst - II

Aptask Global Workforce (AGW) is seeking a Sr. Analyst - II for a 6 month contract position with our client located in Foster City, CA. This position is fully remote and can pay up to $100.59/hr depending on experience.

Summary:
The MES Operations Analyst/Developer is responsible for implementing, configuring, supporting, and enhancing the Manufacturing Execution System (MES) to enable compliant and efficient pharmaceutical/biotech manufacturing operations. This role supports the client's 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 continuous improvements across the MES ecosystem.

Responsibilities:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Qualifications:

• 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 MES systems (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, MES infrastructure components, and container-based deployments (OCP/NKP).
• Ability to work independently, manage multiple priorities, and support off-hours or on-call requirements.
• Only candidates available and ready to work directly as ApTask employees will be considered for this position.

Desired skills:

• Experience migrating MES system 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 in MES systems, GAMP 5, ITIL, Lean Six Sigma, or equivalent.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website ;br>
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.