MES Change Specialist – Regulated Pharma Ops

Dawar Consulting; Hillsboro (IN); On-site; USD 140,000 - 150,000; Full time

Job summary

Dawar Consulting seeks a MES Change Specialist to join a highly automated pharmaceutical manufacturing facility in Hillsboro, OR. The role supports design, configuration, testing, validation, and maintenance of MES and electronic batch documentation.

You will work cross-functionally with Manufacturing, Quality, IT/OT, Automation, and Master Data teams to manage MES changes, ensure regulatory compliance, and improve manufacturing efficiency.

Qualifications

• Bachelor’s degree or Master’s in a relevant field with 3–5 years in MES/EBR or regulated manufacturing.
• Hands-on construction, testing, and validation of computerized systems.
• Experience with electronic change control systems (Veeva Quality, TrackWise).
• Knowledge of CSV, CSA, GAMP, and quality systems in regulated environments.

Responsibilities

• Lead requirements gathering and assessments for MES modifications.
• Translate requirements into MES recipe and workflow specifications.
• Develop and execute CSV protocols, including CV and FV testing.

Skills

MES knowledge

Change management

Data analysis

Regulatory compliance

Documentation

Cross-functional collaboration

Troubleshooting

Project coordination

Education

Bachelor’s degree in a relevant field

Master’s degree

Tools

Veeva Quality

TrackWise

SAP

Rockwell Automation

Job description

Dawar Consulting seeks a MES Change Specialist to join a highly automated pharmaceutical manufacturing facility in Hillsboro, OR. The role supports design, configuration, testing, validation, and maintenance of MES and electronic batch documentation.

You will work cross-functionally with Manufacturing, Quality, IT/OT, Automation, and Master Data teams to manage MES changes, ensure regulatory compliance, and improve manufacturing efficiency.