MES Change Lead — CSV & EBR Expert (Onsite Hillsboro)

Actalent

Hillsboro (OR)

On-site

USD 11,000 - 16,000

Full time

4 days ago

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Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account (HSA)

Job summary

Actalent seeks a MES Change Specialist to design, validate, and maintain MES recipes and electronic documentation in a Hillsboro, OR facility. You will collaborate across manufacturing, IT/OT, quality, and master data teams to ensure compliant electronic batch records and workflows.

The role emphasizes CV/FV testing, CSV activities, and deviations resolution within a formal change management process, with a focus on cross-functional collaboration and regulatory compliance.

Qualifications

Bachelor's degree in a relevant field with MES/electronic batch record experience in regulated manufacturing.
Experience constructing, testing, and validating computerized systems in a regulated environment.
Experience using electronic change management systems like TrackWise or Veeva to coordinate cross-functional activities.

Responsibilities

Troubleshoot automation-related production failures to maintain reliability.
Analyze system performance data for process improvements and cost reductions.
Lead user requirement gathering and assess MES modifications.

Skills

MES

Electronic batch records

CSV/CSA/GAMP

TrackWise

Veeva

Rockwell automation

SAP

HMI/PLC

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

TrackWise

Veeva

SAP

HMI/PLC

Job description

The role emphasizes CV/FV testing, CSV activities, and deviations resolution within a formal change management process, with a focus on cross-functional collaboration and regulatory compliance.

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