MES Change Specialist

Consultant Specialists, Inc. (CSI); Hillsboro (OR); On-site; USD 100,000 - 150,000; Full time

Job summary

Consultant Specialists, Inc. seeks a MES Change Specialist – Process & Compliance for a highly automated pharmaceutical facility. You’ll drive MES recipe/workflow design, testing, validation, and change management to keep electronic batch records compliant.

Required: a Bachelor’s degree with 3–5 years MES/EBR experience in regulated manufacturing (or Master’s). Hands-on CSV/CSA validation experience and work with electronic change management systems like TrackWise or Veeva.

Qualifications

• Bachelor’s degree or Master’s with 3–5 years MES/EBR experience in regulated manufacturing.
• Hands-on experience with CSV/CSA validation and computerized system construction.
• Strong background in electronic change management systems (TrackWise, Veeva).
• Understanding of SAP, MES, PLCs, HMIs, and automation systems.
• Experience with sterile manufacturing processes (prep, filling, inspection, packaging).
• Ability to own changes from initiation through closure.

Responsibilities

• Lead user requirement gathering and translate needs into MES recipe/workflow requirements.
• Own CSV activities: requirements, test script authoring, CV/FV execution, deviation management.
• Troubleshoot mechanical/automation issues and support MES investigations.
• Build, test, validate, and maintain MES changes through the full lifecycle.
• Draft and execute test plans for new or modified MES recipes.
• Support MES components of site initiatives (capital projects, tech transfers, DS/DP changes, launches).
• Provide audit support, demos, and responses for MES regulatory topics.
• Identify efficiency improvements using system performance data and analytics.
• Collaborate cross-functionally with Manufacturing, P&C, IT/OT, Master Data, and Quality.

Skills

CSV/validation testing

TrackWise

Veeva

SAP

MES

PLCs

HMIs

Automation systems

Sterile manufacturing processes

Education

Bachelor’s degree + 3–5 years MES/EBR experience (or Master’s degree)

Master’s degree in a related field

Tools

TrackWise

Veeva

GAMP

Job description

MES Change Specialist – Process & Compliance (Manufacturing)

Join our Process & Compliance team supporting a highly automated pharmaceutical manufacturing facility. In this role, you’ll drive MES recipe/workflow design, testing, validation, and change management to ensure compliant, efficient electronic batch record operations across HTO.

What You’ll Do

• Lead user requirement gathering and translate operational needs into MES recipe/workflow requirements
• Own CSV activities: requirements, test script authoring, CV/FV execution, and deviation management
• Troubleshoot mechanical/automation issues and support MES-related investigations
• Build, test, validate, and maintain MES changes through the full change‑management lifecycle
• Draft and execute test plans for new or modified MES recipes
• Support MES components of site initiatives (capital projects, tech transfers, DS/DP changes, launches)
• Provide audit support, demos, and responses for MES-related regulatory topics
• Identify efficiency improvements using system performance data and analytics
• Collaborate cross-functionally with Manufacturing, P&C, IT/OT, Master Data, and Quality

What You Bring

• Bachelor’s degree + 3–5 years MES/EBR/computerized systems experience in regulated manufacturing (or Master’s degree)
• Hands‑on experience with computerized system construction, testing, and validation (CSV/CSA, GAMP)
• Strong background in electronic change management systems (TrackWise, Veeva, etc.)
• Understanding of SAP, MES, PLCs, HMIs, and automation systems
• Experience with sterile manufacturing processes (prep, filling, inspection, packaging)
• Ability to own changes from initiation through closure