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 - Work on MES projects from start to finish: requirements gathering, design, configuration, testing, deployment and Hypercare.
- Analyse manufacturing processes and turn them into MES functional and technical requirements, workflows and configurations.
- Configure MES solutions to fit each client's operations, including electronic batch records (EBR), recipes, production workflows and master data.
- 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.
- Find and fix system issues quickly to keep production downtime low.
Compliance & Validation
- Apply GMP, GAMP 5, data integrity (ALCOA+), EU Annex 11 and 21 CFR Part 11 to all MES work.
- 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) principles.
- Help with deviations, root-cause analysis and corrective and preventive actions (CAPA).
Requirements
- 2+ years of MES implementation or consulting experience in pharmaceutical, biotech or life sciences.
- Hands-on experience with at least one major MES platform, such as Leucine MES, Körber PAS-X, Emerson Syncade, Siemens Opcenter, FactoryTalk PharmaSuite or GE Proficy.
- A solid understanding of pharmaceutical manufacturing processes, electronic batch records, recipes and production execution.
- Practical experience with MES configuration, documentation, testing and validation support.
- Knowledge of system integration, including ERP–MES interfaces, L3–L2 integration and APIs.
- The ability to turn requirements into MES documentation, workflows, configurations and test cases.
- Strong analytical, problem-solving and troubleshooting skills.
- Excellent communication, coordination and stakeholder management.
- Comfortable working on your own or as part of a team.
Mandatory:
- Working knowledge of GMP, GAMP 5, data integrity, EU Annex 11 and 21 CFR Part 11, applied in MES work.
- Hands-on experience with batch processes in pharmaceutical or biotech manufacturing.
- Proven experience with MES platforms, electronic batch records, testing and validation.
Nice to Have:
- Experience with digital transformation or Industry 4.0 initiatives.
- Experience with cloud-based or SaaS MES solutions.
- Certification in an MES platform or related technology.
- Working knowledge of SQL Server or Oracle databases.
- Hands-on SAP integration experience, for example PP-PI, MM and QM.
Benefits
- Be part of a fast-growing SaaS company transforming the future of pharmaceutical manufacturing through cutting-edge technology
- Collaborate with a passionate, high-performing team building innovative AI-powered digital solutions
- Take ownership of impactful client implementations from day one, with ample opportunities for learning, career growth, and professional development
- Enjoy a competitive compensation package designed to reward your contributions
- Comprehensive Health Insurance with industry-leading coverage for your peace of mind
- Complimentary Meals & Refreshments: Stay energized with unlimited breakfast, lunch, snacks, and dinner provided at the office
- Family-Friendly Leave Policies, including Paternity Leave and Compassionate Leave, to support you through life's important moments