MES Engineer II

Unicon Pharma Inc; Portsmouth (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Unicon Pharma Inc. seeks an experienced MES/gLIMS Validation Specialist to support the implementation and validation of MES-gLIMS interfaces in a GMP-regulated manufacturing environment.

You will lead validation activities, develop and execute validation protocols, test scripts, and testing activities, and collaborate with Quality, Manufacturing, Automation, IT, and Process Owners to ensure compliance with GMP, CSV, SOPs, and regulatory requirements.

Qualifications

• Bachelor’s degree in STEM, Engineering, Life Sciences, or Computer Science.
• Strong experience with MES/LIMS and CSV.
• Experience in GMP-regulated pharmaceutical/biotech manufacturing.
• Knowledge of MES-LIMS integration and validation testing.
• Experience with deviations, Change Controls, CAPAs, and TrackWise preferred.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Lead MES/gLIMS interface validation activities and validation deliverables.
• Develop and execute validation protocols, test scripts, and testing activities.
• Support requirements gathering, system integration, implementation, and MES recipe configuration.
• Partner with Quality, Manufacturing, Automation, IT, and Process Owners.
• Ensure compliance with GMP, CSV, global/local SOPs, and regulatory requirements.
• Support deviations, Change Controls, CAPAs, and TrackWise activities.

Skills

MES/LIMS validation

CSV testing

GMP experience

Cross-functional collaboration

Education

Bachelor's degree in STEM/Engineering/CS

Job description

We are seeking an experienced MES / gLIMS Validation Specialist to support the implementation and validation of MES-gLIMS interfaces in a GMP-regulated manufacturing environment.

Key Responsibilities

• Lead MES/gLIMS interface validation activities and validation deliverables.
• Develop and execute validation protocols, test scripts, and testing activities.
• Support requirements gathering, system integration, implementation, and MES recipe configuration.
• Partner with Quality, Manufacturing, Automation, IT, and Process Owners.
• Ensure compliance with GMP, CSV, global/local SOPs, and regulatory requirements.
• Support deviations, Change Controls, CAPAs, and TrackWise activities.

Requirements

• Bachelor’s degree in STEM, Engineering, Life Sciences, or Computer Science.
• Strong experience with MES/LIMS and Computer System Validation (CSV).
• Experience in GMP-regulated pharmaceutical/biotech manufacturing.
• Knowledge of MES-LIMS integration, validation testing, and quality systems.
• Experience with deviations, Change Controls, CAPAs, and TrackWise preferred.
• Strong project management, communication, and cross-functional collaboration skills.