MES Systems Engineer — Digital Manufacturing & Validation

BioSpace

Indianapolis (IN)

On-site

USD 65,000 - 158,000

Full time

2 days ago

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Job summary

Lilly is seeking an MES System Engineer at the Indianapolis IDAP site. The role focuses on implementing, configuring, and sustaining the MES to support device assembly and packaging operations, with emphasis on compliance and paperless manufacturing.

The successful candidate will work with Operations, Quality, Engineering, and IT to deliver validated MES solutions, ensure proper documentation, and enable continuous improvement in a regulated pharmaceutical environment.

Qualifications

Experience supporting MES in a regulated manufacturing environment, ideally device assembly or packaging.
Working knowledge of cGMP and Computer System Validation (CSV) frameworks.
Ability to interpret process requirements and translate them into MES configurations or electronic batch records.
Strong troubleshooting skills, with the ability to investigate system issues, identify root causes, and implement sustainable solutions.

Responsibilities

Implement, configure, and support the MES platform at IDAP, ensuring it meets operational, quality, and compliance needs.
Collaborate with Operations, Engineering, Quality, and IT to deploy and sustain MES capabilities.
Lead site testing/validation activities (IQ, PQ) to ensure system readiness and traceability.
Develop system documentation, SOPs, training materials, and user guides for IDAP operations.