MES Consultant: Pharmaceutical & Biotech Manufacturing

Leucine, Inc.; Bengaluru; Hybrid; INR 1.500.000 - 2.800.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Comprehensive Health Insurance

Zusammenfassung

Leucine, Inc. is seeking an experienced MES Consultant to implement, configure and improve MES solutions for pharmaceutical and biotech clients in Bengaluru.

You will own work packages across the full delivery lifecycle, ensure regulatory alignment, and drive digital manufacturing transformations. You will collaborate with cross-functional teams, translate manufacturing processes into MES configurations, and deliver validated, compliant solutions that meet customer requirements and regulator

Qualifikationen

• 8-15 years of MES implementation or consulting experience in pharma/biotech.
• Hands-on experience with at least one major MES platform.
• Strong understanding of pharmaceutical manufacturing processes, electronic batch records, recipes, workflows and production execution.
• Experience with MES configuration, testing, implementation and validation support.
• Knowledge of system integration, including ERP-MES interfaces, L3-L2 systems and APIs.
• Ability to analyse requirements and turn them into MES documentation, workflows, configurations and test cases.
• Strong analytical, problem-solving and troubleshooting skills.
• Excellent communication, coordination and stakeholder management skills.
• Able to work independently on your own work packages while contributing to the wider project team.

Aufgaben

• Lead Delivery & Implementation of MES projects through full lifecycle: requirements, design, configuration, testing, deployment and Hypercare.
• Analyse manufacturing processes and translate into MES requirements, workflows and configurations.
• Configure MES solutions, including electronic batch records and recipes, to client needs.
• Design and deliver integrations with ERP, LIMS, WMS, QMS and other systems.
• Apply GMP, GAMP 5, data integrity, EU Annex 11 and 21 CFR Part 11 throughout MES activities.
• Prepare validation deliverables and support execution (IQ/OQ/PQ) in CSV/CSA framework.
• Support deviation handling, CAPA and root-cause analysis.
• Run user training and produce end-user / technical documentation.
• Drive continuous improvement and system optimization.
• Collaborate with Process, Production, QA, Validation, Automation and IT stakeholders.

Kenntnisse

GMP & GAMP5

Data integrity

21 CFR Part 11

MES configuration

ERP-MES integration

Project ownership

Regulatory validation

Tools

Leucine MES

Emerson Syncade

Siemens Opcenter

GE Proficy

Körber PAS-X

Jobbeschreibung

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 looking for an experienced MES (Manufacturing Execution System) Consultant to join our growing team. You'll implement, configure and improve MES solutions for pharmaceutical and biotech clients. The goal is to help them run manufacturing more efficiently, stay compliant and move forward with their digital transformation. You'll work across the whole delivery lifecycle: design, configuration, testing, documentation, validation support and go-live. You'll own defined work packages and deliver compliant, reliable digital manufacturing solutions that meet each customer's requirements and regulators' expectations.

Key Responsibilities

• Delivery & Implementation Lead and support MES projects through the full lifecycle: requirements gathering, design, configuration, testing, deployment and Hypercare.
• Analyse manufacturing business processes and turn them into MES functional and technical requirements, workflows and configurations.
• Configure and tailor MES solutions, including electronic batch records (EBR), recipes and production workflows, to fit client needs.
• Design and deliver integrations with ERP (for example SAP), LIMS, WMS, QMS and other enterprise systems.
• Compliance & Validation Apply GMP, GAMP 5, data integrity (ALCOA+), EU Annex 11 and 21 CFR Part 11 requirements throughout all MES work.
• Prepare validation deliverables and support execution, including specifications, test scripts (IQ/OQ/PQ) and traceability, following computerized system validation (CSV/CSA) principles.
• Support deviation handling, root-cause analysis and corrective and preventive actions (CAPA).
• Support & Continuous Improvement Troubleshoot and resolve system issues quickly to keep production downtime to a minimum.
• Run user training, produce end-user and technical documentation, and provide support after go-live.
• Drive continuous improvement and system optimization.
• Collaboration & Ownership Work closely with Process, Production, QA, Validation, Automation, Engineering and IT stakeholders. Manage your assigned priorities and work packages, report progress clearly, and escal... early.

Qualifications

8-15 years of experience in MES implementation or consulting in the pharmaceutical, biotech or life sciences industry.

Hands-on experience with at least one major MES platform, such as Leucine MES, Emerson Syncade, Siemens Opcenter, GE Proficy or Körber PAS-X, or an equivalent.

Strong understanding of pharmaceutical manufacturing processes, electronic batch records, recipes, workflows and production execution.

Practical experience with MES configuration, documentation, testing, implementation and validation support.

Knowledge of system integration, including ERP-MES interfaces, L3-L2 systems and APIs.

Ability to analyse requirements and turn them into MES documentation, workflows, configurations and test cases.

Strong analytical, problem-solving and troubleshooting skills.

Excellent communication, coordination and stakeholder management skills.

Able to work independently on your own work packages while contributing to the wider project team.

Mandatory Skills

• Working knowledge of GMP, GAMP 5, data integrity, EU Annex 11 and 21 CFR Part 11, applied across MES activities.
• Hands-on experience with batch processes in pharmaceutical or biotech manufacturing.
• Proven experience with MES platforms, electronic batch records, testing and validation, plus exposure to WMS and QMS.
• A track record of owning defined work packages through to delivery in a regulated manufacturing environment.

Preferred Qualifications

• Experience with digital transformation or Industry 4.0 initiatives.
• Exposure to cloud-based / SaaS MES solutions.
• Certification in an MES platform or related technology.
• Working knowledge of SQL Server or Oracle databases.
• Hands-on experience with SAP integration (for example PP-PI, MM and QM touchpoints).

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.

Benefits

• Enjoy a competitive compensation package designed to reward your contributions.
• Comprehensive Health Insurance with industry-leading coverage for your peace of mind.

Complime