17 hours ago
Pune, IndiaStaff+
Responsibilities
- Define Siemens Opcenter Pharma architecture, implementation standards, validation approach, governance model, and deployment roadmap.
- Design and implement Electronic Batch Records, Master Batch Records, recipe execution, weigh-and-dispense, review-by-exception, quality management, genealogy, and material tracking capabilities.
- Architect integrations with ERP, LIMS, QMS, WMS, serialization platforms, PLCs, SCADA systems, historians, laboratory systems, and manufacturing equipment.
- Lead customer workshops, design reviews, validation activities, testing cycles, cutover planning, production stabilization, and rollout programs.
- Coordinate cross-functional teams during implementation and go-live phases.
- Collaborate with manufacturing operations, quality assurance, engineering, supply chain, IT, OT, vendors, and business stakeholders.
- Mentor delivery teams and establish governance standards for architecture, documentation, configuration, validation, and DevOps practices.
- Drive digital manufacturing transformation initiatives across pharmaceutical and medical device manufacturing facilities.
Requirements
- 12–15 years of experience in MES, manufacturing IT, shopfloor systems, or digital manufacturing.
- Strong expertise in Siemens Opcenter Execution Pharma and Electronic Batch Records.
- Proven experience implementing MES solutions in pharmaceutical, biotechnology, or medical device manufacturing environments.
- MES or shopfloor implementation experience, plus pre-sales and solutioning experience, is mandatory.
- Experience with regulated MES implementation and the validation lifecycle.
- Knowledge of batch execution, recipe management, quality processes, genealogy, material controls, production execution, work order management, product traceability, and non-conformance management.
- Expertise in solution architecture, integration design, security, performance engineering, and technical governance.
- Bachelor’s or Master’s degree in engineering, manufacturing, information technology, life sciences, computer science, or a related discipline.
- Ability to lead validation activities, testing cycles, cutover planning, production stabilization, rollout programs, and cross-functional implementation teams.
- Strong communication, consulting, stakeholder management, and leadership skills.
Categories
Solutions Engineering
About Capgemini
Capgemini is a global IT services and consulting firm that delivers strategy, cloud, AI, software engineering, and managed services to large enterprises and public-sector clients. Founded in 1967 and headquartered in Paris, it is publicly traded on Euronext Paris and operates in 50+ countries. The group expanded its engineering capabilities by acquiring Altran in 2020, now operating as Capgemini Engineering.