{"id":2704494,"url":"https://alion.io/job/leucine-mes-engineer-pharmaceutical-biotech-manufacturing","title":"MES Engineer: Pharmaceutical & Biotech Manufacturing","company":{"id":4457,"name":"Leucine","domain":"leucine.io","url":"https://alion.io/company/leucine","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Enterprise Apps","role_family":"Enterprise Apps","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"LIMS","optional":false},{"name":"SQL","optional":true}],"status":"live","first_seen_at":"2026-10-16T12:10:31Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-21T16:18:36Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"12 of the top 15 pharma generic companies in the world trust Leucine to manufacture the drugs that reach millions of patients every day.\nPharma 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.\nLeucine 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.\nAbout the Role:\n\nWe're hiring an MES (Manufacturing Execution System) Engineer to help pharmaceutical and biotech manufacturers move from paper to digital batch execution.\nYou'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.\nWhat You'll Do:\nDelivery & Implementation\nWork on MES projects from start to finish: requirements gathering, design, configuration, testing, deployment and Hypercare. \nAnalyse manufacturing processes and turn them into MES functional and technical requirements, workflows and configurations. \nConfigure MES solutions to fit each client's operations, including electronic batch records (EBR), recipes, production workflows and master data. \nDesign 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. \nFind and fix system issues quickly to keep production downtime low.\nCompliance & Validation\nApply GMP, GAMP 5, data integrity (ALCOA+), EU Annex 11 and 21 CFR Part 11 to all MES work. \nPrepare 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. \nHelp with deviations, root-cause analysis and corrective and preventive actions (CAPA).\nRequirements\n2+ years of MES implementation or consulting experience in pharmaceutical, biotech or life sciences. \nHands-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. \nA solid understanding of pharmaceutical manufacturing processes, electronic batch records, recipes and production execution. \nPractical experience with MES configuration, documentation, testing and validation support. \nKnowledge of system integration, including ERP-MES interfaces, L3-L2 integration and APIs. \nThe ability to turn requirements into MES documentation, workflows, configurations and test cases.\nStrong analytical, problem-solving and troubleshooting skills. \nExcellent communication, coordination and stakeholder management. \nComfortable working on your own or as part of a team.\nMandatory:\nWorking knowledge of GMP, GAMP 5, data integrity, EU Annex 11 and 21 CFR Part 11, applied in MES work. \nHands-on experience with batch processes in pharmaceutical or biotech manufacturing. \nProven experience with MES platforms, electronic batch records, testing and validation. \nNice to Have:\nExperience with digital transformation or Industry 4.0 initiatives. \nExperience with cloud-based or SaaS MES solutions. \nCertification in an MES platform or related technology. \nWorking knowledge of SQL Server or Oracle databases. \nHands-on SAP integration experience, for example PP-PI, MM and QM.\nBenefits\nBe part of a fast-growing SaaS company transforming the future of pharmaceutical manufacturing through cutting-edge technology\nCollaborate with a passionate, high-performing team building innovative AI-powered digital solutions\nTake ownership of impactful client implementations from day one, with ample opportunities for learning, career growth, and professional development\nEnjoy a competitive compensation package designed to reward your contributions\nComprehensive Health Insurance with industry-leading coverage for your peace of mind\nComplimentary Meals & Refreshments: Stay energized with unlimited breakfast, lunch, snacks, and dinner provided at the office\nFamily-Friendly Leave Policies, including Paternity Leave and Compassionate Leave, to support you through life's important moments","description_format":"text","description_chars":4363,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Health insurance","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Artificial Intelligence","Industrial 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