MES Architect - Lead Houston API Site & Validation

BioSpace

Houston (TX)

On-site

USD 129,000 - 189,000

Full time

3 days ago
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Benefits offered by this job

Onsite role in Houston

Job summary

Lilly is seeking a MES Architect for the Houston API Manufacturing Site to own the MES architecture, lead the technical team, and ensure validation rigor across the system's lifecycle. You will partner with Operations, Quality, Engineering, and IT to stand up and sustain MES capabilities at a greenfield site.

The role requires 8+ years of experience with Emerson Syncade, strong leadership, and deep knowledge of CSV, 21 CFR Part 11, and GAMP 5. This is an onsite position in Houston, Texas.

Qualifications

  • Bachelor's degree in a related technical field.
  • 8+ years of experience with MES Syncade in design, implementation, and validation in a GMP-regulated industry.
  • Experience authoring and validating Master Batch Records (MBRs) and electronic batch records (EBRs).
  • Experience with Emerson Syncade.

Responsibilities

  • Own end-to-end MES architecture for the Houston site.
  • Define standards for the MES platform and collaborate with global teams.
  • Lead requirements, design, and decision-making across the implementation lifecycle.
  • Architect integrations between MES and ERP/SCADA systems.
  • Lead site testing, validation, and CSV activities.
  • Mentor MES engineers and serve as site MES custodian.
  • Support startup, readiness, and go-live activities.

Skills

Leadership
Validation lifecycle
Regulatory compliance
Communication
Cross-functional collaboration

Education

Bachelor's degree in a related technical field

Tools

Emerson Syncade
Tulip

Job description

Lilly is seeking a MES Architect for the Houston API Manufacturing Site to own the MES architecture, lead the technical team, and ensure validation rigor across the system's lifecycle. You will partner with Operations, Quality, Engineering, and IT to stand up and sustain MES capabilities at a greenfield site.

The role requires 8+ years of experience with Emerson Syncade, strong leadership, and deep knowledge of CSV, 21 CFR Part 11, and GAMP 5. This is an onsite position in Houston, Texas.

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