16 Oct
|
Leucine
|
Bengaluru
12 of the top 15 pharma generic companies in the world trust Leucine to manufacture the drugs that reach millions of patients every day.
Pharma manufacturing is one of the last large industries still running on paper, Excel, and tribal knowledge. A single missed step in a batch record can mean a recall, a regulatory warning, or a drug that should never have left the plant.
Leucine is the AI platform replacing all of it. Series A, backed by top-tier global investors, 60+ pharma enterprises in production, and the team that's going to define this category.
About the Role:
We're hiring an MES (Manufacturing Execution System) Engineer to help pharmaceutical and biotech manufacturers move from paper to digital batch execution.
You'll implement, configure and improve MES solutions for our clients, and every project has to meet strict GMP and data integrity standards. You'll report to a Lead or Senior Engineer, and you'll own work packages as your experience grows.
What You'll Do:
Delivery & Implementation
1. Work on MES projects from start to finish: requirements gathering,
design, configuration, testing, deployment and Hypercare.
2. Analyse manufacturing processes and turn them into MES functional and technical requirements, workflows and configurations.
3. Configure MES solutions to fit each client's operations, including electronic batch records (EBR), recipes, production workflows and master data.
4. Design and deliver integrations with enterprise systems such as ERP (for example SAP), LIMS, WMS and QMS, and with shop-floor (L2) equipment and automation systems.
5. Find and fix system issues quickly to keep production downtime low.
Compliance & Validation
1. Apply GMP, GAMP 5, data integrity (ALCOA+), EU Annex 11 and 21 CFR Part 11 to all MES work.
2. Prepare validation deliverables and help execute them, including specifications, IQ/OQ/PQ test scripts and traceability matrices. Follow computerized system validation (CSV) and computer software assurance (CSA)
📌 MES Engineer: Pharmaceutical (Bengaluru)
🏢 Leucine
📍 Bengaluru