Onsite MES Change Leader – Pharma Manufacturing

Sharp Decisions; Hillsboro (OR); On-site; USD 82,000 - 116,000; Part time

Job summary

Sharp Decisions is seeking an MES Change Specialist for a 6-month on-site contract in Hillsboro, OR. You'll own CSV validation, MES configuration, and CV/FV testing, collaborating across IT/OT, P&C, and manufacturing to ensure compliant electronic batch records.

Strong TrackWise and Veeva experience, plus knowledge of SAP/MES/PLC/HMI, are essential. Onsite support for sterile processes and regulatory readiness is expected.

Qualifications

• Bachelor's or Master’s degree in a relevant field with 3–5 years MES/EBR experience.
• Experience constructing, testing, and validating computerized systems.
• Prior use of TrackWise and Veeva for change management and CSV.
• Background in IT/OT, quality systems, and validation (CSV/CSA, GAMP).
• Knowledge of SAP, MES, PLC, and HMI in regulated manufacturing.
• Experience with sterile pharmaceutical manufacturing is a plus.

Responsibilities

• Troubleshoot automation and mechanical failures in production.
• Leverage data analytics to improve performance and reduce costs.
• Lead user requirements for MES changes and assess CSV/validation needs.
• Own CSV functions, write tests, and execute validation activities.
• Translate requirements into CSV/test protocols for CV/FV testing.
• Develop and execute CV/FV test protocols for MES recipes/workflows.
• Investigate deviations from CV/FV testing and document outcomes.
• Plan and review MES changes across manufacturing processes.
• Monitor project schedules and escalate risks timely.
• Draft test plans for MES changes and new recipes; produce reports.
• Own MES deviations and ensure corrective actions are effective.
• Support MES in capital projects, tech transfers, DS/DP changes, shutdowns.
• Provide MES audit support and regulatory finding closures when needed.

Skills

MES systems

CSV/CSA

Electronic batch records

TrackWise

Veeva

Change management

Rockwell troubleshooting

Automation knowledge

Education

Bachelor's degree

Master's degree

Tools

TrackWise

Veeva

SAP

Rockwell Automation

Job description

Sharp Decisions is seeking an MES Change Specialist for a 6-month on-site contract in Hillsboro, OR. You'll own CSV validation, MES configuration, and CV/FV testing, collaborating across IT/OT, P&C, and manufacturing to ensure compliant electronic batch records.

Strong TrackWise and Veeva experience, plus knowledge of SAP/MES/PLC/HMI, are essential. Onsite support for sterile processes and regulatory readiness is expected.