MES Change Lead | Regulated Pharma Manufacturing

Tailored Management; Hillsboro (OR); On-site; USD 92,000 - 96,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

EAP

Job summary

Tailored Management in Hillsboro, OR is seeking a MES Change Specialist for a fully onsite role in a state‑of‑the‑art pharmaceutical environment. You will collaborate with manufacturing, IT, and quality teams to design, test, and maintain electronic documentation and MES changes across operations.

The ideal candidate holds a degree with 3–5 years of MES/EBR experience, plus hands‑on expertise with TrackWise and Veeva, and will own change management activities and CSV testing protocols.

Qualifications

• Bachelor's or Master's degree in a relevant field with 3–5 years MES/EBR experience.
• Experience in construction, testing and validation of computerized systems.
• Experience with electronic change management systems (TrackWise, Veeva) across departments.
• Knowledge of SAP, MES, PLC and HMI in automation environments.
• Experience in sterile pharmaceutical manufacturing.
• Ownership of changes in a change management system (e.g., Veeva) from initiation to closure.
• Troubleshooting Rockwell systems; remote or on-site support.
• EBR/MES deployment project experience preferred.

Responsibilities

• Troubleshoot mechanical or automation failures in production.
• Analyze data to identify opportunities for cost reduction and efficiency gains.
• Lead user requirements and assess MES modification needs.
• Own CSV functions including test script definition and execution.
• Translate operational needs into recipe/workflow requirements for CSV tests.
• Develop, author, and execute CV and FV test protocols for MES recipes.
• Investigate deviations from CV and FV testing.
• Plan and review MES changes across manufacturing processes per change control.
• Monitor project schedule and escalate concerns to leadership.
• Draft test plans and comprehensive reports for new recipes.
• Own MES deviations, ensuring effective corrective actions.
• Support MES components of capital projects, tech transfers, DS/DP changes, shutdowns, launches.
• Serve as audit support for MES; respond to regulatory findings when required.

Skills

MES knowledge

Electronic Batch Records

Change management

CSV validation

Rockwell troubleshooting

SAP knowledge

Education

Bachelor’s degree in a relevant field

Master’s degree in a relevant field

Tools

TrackWise

Veeva

Rockwell

Job description

Tailored Management in Hillsboro, OR is seeking a MES Change Specialist for a fully onsite role in a state‑of‑the‑art pharmaceutical environment. You will collaborate with manufacturing, IT, and quality teams to design, test, and maintain electronic documentation and MES changes across operations.

The ideal candidate holds a degree with 3–5 years of MES/EBR experience, plus hands‑on expertise with TrackWise and Veeva, and will own change management activities and CSV testing protocols.