Nagarro

Healthcare

AssociateStaffEngineer,SiemensOpCenter

India FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for not-applicable candidates.

The Brief

“Associate Staff Engineer, Siemens OpCenter at Nagarro. Skills: Siemens OpCenter Pharma (MES), end-to-end implementations, Recipe Authoring / MBR (Manufacturing Batch Record) design, ISA S88 standards, Electronic Batch Records (EBR) design and validation, GxP systems, CSV (Computer System Validation), SDLC methodologies, 21 CFR Part 11 compliance. Lead Siemens OpCenter MES solution design and implementation. Analyze business process flows and translate them into MES recipes and workflows”

Industry & Context.

Healthcare
Problems you'll solve

Analyze business process flows; translate into MES recipes and workflows; Identify and manage quality and manufacturing risks

What They're Looking For.

Must Have

Siemens OpCenter Pharma (MES) with end-to-end implementations, Recipe Authoring / MBR (Manufacturing Batch Record) design, ISA S88 standards and batch process modeling, designing operations, unit procedures, and recipes aligned with MBR, pharmaceuticaliotech manufacturing processes, Electronic Batch Records (EBR) design and validation, GxP systems, CSV (Computer System Validation), and SDLC methodologies, 21 CFR Part 11 compliance and regulatory requirements, quality and manufacturing impacts in MES implementations, MOM platform and integration capabilities, process development and manufacturing execution in pharmaiotech domain, stakeholder management, ability to work with cross-functional teams, leading teams or handling complex project deliveries

What You'll Do.

Lead Siemens OpCenter MES solution design and implementation

Analyze business process flows and translate them into MES recipes and workflows

Design and develop recipes

and unit procedures aligned with S88 and MBR

and validation activities

Ensure compliance with GxP

and validation standards (CSV)

Conduct requirement workshops and convert them into functional and technical MES designs

and production deployment activities

Identify and manage quality and manufacturing risks during MES implementation

Work on integration of MES with upstream/downstream systems

Provide technical leadership

and governance for MES projects

Drive continuous improvements and innovation within MES/MOM landscape

How You'll Work.

Team & Collaboration

Collaborate with business and manufacturing teams to ensure process alignment and compliance; ability to work with cross-functional teams

Process & Methodology

handling complex project deliveries, MES solution design and implementation, governance for MES projects

Full Job Description

👋🏼We're Nagarro, we are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale across all devices and digital mediums, and our people exist everywhere in the world (17500+ experts across 39 countries, to be exact). Our work culture is dynamic and non-hierarchical. We are looking for great new colleagues. That is where you come in! REQUIREMENTS * Total experience: 4+ years * Strong experience in Siemens OpCenter Pharma (MES) with end-to-end implementations * Mandatory experience in Recipe Authoring / MBR (Manufacturing Batch Record) design * Good understanding of ISA S88 standards and batch process modeling * Experience in designing operations, unit procedures, and recipes aligned with MBR * Strong knowledge of pharmaceutical/biotech manufacturing processes * Hands-on experience with Electronic Batch Records (EBR) design and validation * Experience with GxP systems, CSV (Computer System Validation), and SDLC methodologies * Good understanding of 21 CFR Part 11 compliance and regulatory requirements * Exposure to quality and manufacturing impacts in MES implementations * Knowledge of MOM platform and integration capabilities * Experience in process development and manufacturing execution in pharma/biotech domain * Strong stakeholder management and ability to work with cross-functional teams * Experience in leading teams or handling complex project deliveries RESPONSIBILITIES * Lead Siemens OpCenter MES solution design and implementation * Analyze business process flows and translate them into MES recipes and workflows * Design and develop recipes, operations, and unit procedures aligned with S88 and MBR * Collaborate with business and manufacturing teams to ensure process alignment and compliance * Drive EBR design, configuration, and validation activities * Ensure compliance with GxP, 21 CFR Part 11, and validation standards (CSV) * Conduct requirement work

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