Sagarika Barua
Kolkata
Summary
Results-driven Service Delivery & Engagement Manager with 15+ years in IT program delivery and Manufacturing Execution Systems (MES) implementation, specializing in Manufacturing and Supply Chain. Proven expertise in Siemens Opcenter, Camstar, Apriso, and other MES solutions within regulated industries, including medical devices. Adept at delivering global projects in compliance with 21 CFR Part 11 and GMP requirements. Strong track record of leading cross-functional teams, managing multi-million-dollar engagement, and ensuring successful end-to-end solution deployment.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Service Delivery Manager
Stryker Corporation
06.2022 - Current
- Managed entire MES operations including Opcenter and Apriso for leading medical device customer - Stryker ensuring 99.9% application uptime and compliance with 21 CFR Part 11.Besides MES managed other 40+ application with multiple Tools and Technologies like Trackwise(RAQA), Labvantage(RAQA), InforEAM(Asset Management) Prisym 360(Labeling) and multiple Inhouse Application.
- Served as primary customer interface for Stryker, ensuring alignment with business priorities and exploring new growth opportunities.
- Led 50+ member cross-functional teams across development, support, and validation established KPI frameworks and improved service reliability.
- Delivered Camstar and Opcenter MES upgrades, integrating with .NET-based custom tools and SQL databases to enhance shop-floor usability and reporting.
- Implemented ITSM best practices for incident, change, and problem management, reducing incident recurrence by 25%.
- Designed Power BI dashboards for operational KPI tracking, SLA compliance, and service health monitoring.
- Involved in Datacenter Migration and planning for 18+ application for Stryker.
- Scored continuous More than 98% Service Delivery score for 36 months till date.
- Recognised by IT Director in Multiple Townhall and received 'Star of the quarter' appreciation in Service Delivery.
MES Validation Lead
Terumo Corporation
10.2019 - 06.2022
- Acted as QCSV lead for MES applications, managing audit trails, electronic signatures, and regulatory validation protocols for Opcenter upgrade.
- Authored Risk Assessment & Mitigation Strategies.
- Authored Requirements Traceability Matrix (RTM) Development.
- Directed defect management, change control, and deviation resolution processes to maintain validated state.
- Performed IQ/OQ/PQ validation activities for MES (Apriso) deployments across multiple sites.
- Ensured documentation adherence to 21 CFR Part 11 and company QMS requirements.
- Partnered with IT teams to implement validated system changes without disrupting operations.
- Successfully led Internal Audit and ISO audits with zero nonconformities in MES and IT operation.
MES Opcenter Support Lead
Johnson and Johnson
01.2016 - 09.2019
- Led global MES support operations for Siemens Opcenter Execution and legacy Camstar systems, supporting 24/7 manufacturing for 10+ sites.
- Managed incident triage, prioritization, and resolution within SLA, reducing recurring MES downtime incidents by 30% for Ethicon and Depuy Synthes and Biosense Webster.
- Directed L1/L2/L3 teams in investigating complex MES issues, performing root cause analysis, and implementing corrective actions.
- Governed the Monthly Maintenance Triage Meeting, CAB calls, alignments, downtime planning, Package and Patch deployment.
- Maintained and updated MES workflows, user roles, and master data in collaboration with manufacturing operations.
- Coordinated ERP-MES interface monitoring and troubleshooting to ensure seamless data exchange.
- Prepared monthly support performance reports and presented KPIs to senior leadership.
- Created knowledge base documents for MES troubleshooting and operational best practices.
MES, .Net Developer/Module Lead
Natsteel
05.2013 - 12.2016
- Provided L1 and L2 support for Inhouse MES for Prefabricated Steel Manufacturing plan based on Singapore.
- Developed complex logic for building new functionality in .Net and SQL.
- Managed system access requests, security roles, and periodic access reviews.
- Assisted with MES testing during system patches, upgrades, and enhancements.
- Partnered with Quality Assurance team to document incidents, deviations, and CAPAs.
- Contributed to creation of MES knowledge base, improving first-call resolution rates.
Support Analyst
Humana and Vale
12.2008 - 05.2013
- Resolved L1 and L2 tickets related to business applications, achieving a 100% SLA compliance rate.
- Wrote and executed basic SQL queries to retrieve, validate, and update data for incident resolution.
- Exposure to OSI PI, Kepware tags, SCADA, HMI interface.
- Used .NET knowledge to troubleshoot application issues and perform small code changes in collaboration with developers.
- Designed and delivered small POC applications to Log tickets for non development environment.
- Developed System Availability, Disk Space utility, Service uptime analytical report in PowerShell to share it across with the IT group and Business Users.
Education
Bachelor of Engineering (BE) - Civil Engineering
Jadavpur University
01.2008
Skills
Delivery Management:
- Project Planning & Execution
- Application Availability
- Service Reliability
- KPI Management
- Digital Manufacturing Transformation
- Manufacturing Supply Chain
MES Platforms:
- Siemens Camstar
- Opcenter Execution
- Delmia Apriso
- ERP-MES Integration
Compliance & Validation:
- 21 CFR Part 11
- ISA 95
- GxP/GMP
Processes:
- IT Service Management
- Incident Management
- Change Management
- Problem Management
- Knowledge Management
Leadership:
- Agile Project Management
- Waterfall Project Management
- Large Team Management
- Stakeholder Engagement
- Customer Relationship Management
Tools:
- Visual Studio
- SQL Server Management Studio
- ServiceNow
- SharePoint
- HPALM
Domain:
- Life Sciences and Health Care
- Medical Devices
- Steel Manufacturing
Technologies:
- NET
- SQL Server
- Power BI
- Scripting
Certification
- ITIL Foundation Certification
- Performance Improvement (PI) Certification
- Lean Bronze
- Domain advisory: Foundation
- Generative AI Foundation Curriculum
- Project Management Professional
Languages
English
First Language
Bengali
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
Hpbbies
- Avid Music Enthusiastic, deep interest in Hindustani Classical Music
- Book Lover
- Nature Explorer
- History Buff
Timeline
Service Delivery Manager
Stryker Corporation
06.2022 - Current
MES Validation Lead
Terumo Corporation
10.2019 - 06.2022
MES Opcenter Support Lead
Johnson and Johnson
01.2016 - 09.2019
MES, .Net Developer/Module Lead
Natsteel
05.2013 - 12.2016
Support Analyst
Humana and Vale
12.2008 - 05.2013
Bachelor of Engineering (BE) - Civil Engineering
Jadavpur University
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