Pharma & MedTech Solution Architect

Capgemini; Pune District; On-site; INR 3,000,000 - 5,400,000; Full time

Job summary

Capgemini is seeking a Solution Architect focused on Pharma & MedTech manufacturing, specializing in Siemens Opcenter Pharma. The role combines MES architecture, validation strategy, and delivery leadership for compliant manufacturing solutions across pharmaceutical and medical device sectors.

The ideal candidate will drive architecture governance, cross-functional collaboration, and pre-sales solutioning while guiding delivery teams through complex MES deployments and regulatory compliance

Qualifications

• Bachelor's or Master's degree in Engineering, Manufacturing, Information Technology, Life Sciences, Computer Science, or a related discipline.
• 12–15 years of experience in MES, manufacturing IT, Shopfloor systems, or digital manufacturing.
• Strong expertise in Siemens Opcenter Pharma/Execution Pharma.
• Experience leading customer workshops, design reviews, validation activities, testing cycles, and go-live rollout programs.
• Proven experience in regulated MES implementations with validation lifecycle knowledge.

Responsibilities

• Define Siemens Opcenter Pharma architecture, implementation standards, validation approach, governance model, and deployment roadmap.
• Design and implement Electronic Batch Records (EBR), Master Batch Records (MBR), Recipe Execution, Weigh-and-Dispense, and Quality Management.
• Architect integrations with ERP, LIMS, QMS, WMS, serialization platforms, PLCs, SCADA systems, and Historians.
• Collaborate with Manufacturing Operations, Quality Assurance, Engineering, IT, and business stakeholders.
• Mentor delivery teams and establish governance standards for architecture, documentation, configuration, validation, and DevOps practices.
• Drive digital manufacturing transformation initiatives across pharma and medical device facilities.

Skills

MES architecture

Pre-sales & solutioning

Stakeholder management

Leadership

Regulatory compliance

Project coordination

Education

Bachelor's or Master's in Engineering/IT/Life Sciences/CS

Tools

Siemens Opcenter Execution Pharma

Electronic Batch Records (EBR)

ERP integration

SCADA integration

Job description

Job Description

Solution Architect - Pharma & MedTech (Siemens Opcenter Pharma)

Location: PAN India

Experience: 12-15 Years

Choosing Capgemini means choosing a place where you'll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what's possible. Join us in helping leading Pharmaceutical, Biotechnology, and Medical Device organizations accelerate their digital manufacturing transformation through compliant MES and Electronic Batch Record solutions.

Role Overview

This is a Solution Architect role focused on Pharma & MedTech manufacturing environments. The position combines MES architecture, validation strategy, regulated manufacturing consulting, pre-sales solutioning, and delivery leadership.

The ideal candidate will have strong expertise in Siemens Opcenter Pharma and proven experience implementing compliant MES solutions supporting Electronic Batch Records (EBR), recipe execution, quality management, material traceability, and regulatory compliance requirements.

MES or Shopfloor implementation experience is mandatory. Pre-sales and solutioning experience is also mandatory.

Key Responsibilities

• Define Siemens Opcenter Pharma architecture, implementation standards, validation approach, governance model, and deployment roadmap.
• Design and implement Electronic Batch Records (EBR), Master Batch Records (MBR), 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.
• 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.

Ideal Candidate Profile

• 12-15 years of experience in MES, Manufacturing IT, Shopfloor Systems, or Digital Manufacturing.
• Strong expertise in Siemens Opcenter Execution Pharma.
• Proven experience implementing MES solutions within Pharmaceutical, Biotechnology, or Medical Device manufacturing environments.
• Excellent communication, consulting, stakeholder management, and leadership skills.
• Bachelor's or Master's degree in Engineering, Manufacturing, Information Technology, Life Sciences, Computer Science, or a related discipline.

Mandatory Skills

• Siemens Opcenter Execution Pharma and Electronic Batch Record (EBR) expertise.
• Regulated MES implementation and validation lifecycle experience.
• Strong knowledge of:
• Experience in Batch Execution, Recipe Management, Quality Processes, Genealogy, and Material Controls.
• Solution Architecture, Integration Design, Security, Performance Engineering, and Technical Governance expertise.

Strong understanding of:

• Production Execution and Work Order Management.
• Product Traceability, Genealogy, Quality, and Non-Conformance Management.

Implementation Experience (Mandatory)

• Experience leading customer workshops, design reviews, validation activities, testing cycles, cutover planning, production stabilization, and rollout programs.
• Ability to coordinate cross-functional teams during implementation and go-live phases.

Pre-Sales & Solutioning Experience (Mandatory)