MES Engineer: Pharmaceutical & Biotech Manufacturing

• 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