MES Engineer-Full job Description
MES Engineer (2 x Positions)
Location: Glasgow
Employment Type: Full‑time, Permanent
Salary: £45,5000 per annum (based on a 37.5‑hour working week)
Role Overview
Operations Helix Ltd is seeking two MES Engineers to support ongoing digital manufacturing and compliance projects across life sciences and advanced manufacturing.
The MES Engineers will provide specialist support for MES systems, Electronic Batch Records (EBR), and system integrations, ensuring compliant, reliable, and efficient operations.
Key Responsibilities
- Provide SME knowledge to the operations team with respect to the MES system.
- Partner with Operations, Supply Chain, Engineering, IT, and Quality functions to ensure efficient and effective MES site support during operational hours.
- Support MES‑related documentation, training, and user onboarding.
- Assist in the rollout of MES upgrades, patches, and system enhancements.
- Ensure all activities align with GxP compliance and quality assurance protocols.
- Design, author, develop, and configure Electronic Batch Records (EBR).
- Implement MES solutions and integrate them with ERP systems and control equipment.
- Document MES configuration and validation of EBRs.
- Work closely with QA and IT teams to maintain audit readiness and ensure robust data integrity across all validated systems.
Skills, Experience & Qualifications Required
Essential Requirements
- Bachelor’s degree in Computer Science, IT, Pharmaceutical Manufacturing, Engineering, or a related technical field.
- Minimum 7 years’ experience working within GMP -regulated manufacturing operations or Minimum five years’ experience within GMP‑regulated operations, of which at least two years must be MES‑related (e.g., MES/EBR implementation, workflow design, configuration, testing, or system support) .
- Strong practical understanding of GMP production operations, including batch execution, material flows, equipment operations, deviation handling, and GMP documentation standards.
- Full understanding of cGMP requirements including 21 CFR Part 11 and EU Annex 11.
- Excellent understanding of GAMP principles, system implementation, and validation concepts.
Desirable Criteria
- Exposure to MES or digital batch record implementation, including configuration, testing, or workflow mapping.
- Familiarity with Exception Management, Deviations, CAPA processes, and Change Control within GMP environments.
- Experience supporting validation activities, audit readiness, and cross‑functional technical investigations.
- Exposure to MES or digital batch record implementation, including configuration, testing, or workflow mapping.
If you meet the above criteria and are looking to contribute to high‑impact digital and compliance projects, we encourage you to apply using the form below.