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IT Program Manager

Role Summary:

The IT Program Manager is responsible for leading the strategy, planning, implementation, and ongoing evolution of programs across life sciences/ manufacturing sites. This role partners with Manufacturing, Quality, Engineering, Supply Chain, Automation, and IT teams to deliver compliant, reliable, and scalable digital manufacturing solutions. The Program Manager oversees complex initiatives from business case development through deployment, validation, adoption, and operational handover. The role ensures the solutions support business objectives, regulatory requirements, data integrity principles, and standardized manufacturing processes. Required strong hands on with any Pharmaceutical/ Life Sciences domain experience in GxP/ GAMP/ 21 CFR Part 11 Regulatory affairs.

Immediate Joiners Only.

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Job Title: IT Program Manager

Experience: 15+ yrs
Location: Hyderabad (Hitech City area)
Employment Type: Full-Time

Key Responsibilities

Lead the end-to-end delivery of the Form Hub implementation from project initiation through deployment and hypercare.
Develop and maintain the project plan, schedule, milestones, budget, RAID log, and executive status reporting.
Coordinate activities across business, IT, infrastructure, security, middleware, application, and vendor teams.
Partner with business stakeholders to facilitate requirements gathering, solution design, testing, deployment, and organizational readiness.
Manage project risks, issues, assumptions, dependencies, and escalation paths.
Ensure compliance with Thermo Fisher PMO governance and project management standards.
Coordinate vendor deliverables and implementation activities.
Track project financials, resource utilization, and milestone achievement.

Stakeholder Communication & Leadership

Serve as the primary point of contact for all project communications across business and IT organizations.
Develop and execute a comprehensive stakeholder communication plan, providing timely, accurate, and transparent updates throughout the project lifecycle.
Build strong relationships with executive sponsors, business leaders, technical teams, and vendors to ensure alignment and successful delivery.
Facilitate Steering Committee meetings, project governance sessions, stakeholder workshops, and executive presentations.
Communicate complex business and technical information in a clear, concise, and executive-friendly manner.
Drive collaboration, resolve conflicts, and influence decision-making across multiple functional organizations.

Required Qualifications

15+ years of enterprise IT Project Management experience.
Proven experience leading large, cross-functional enterprise application implementations.
Demonstrated success delivering projects involving workflow automation, digital platforms, enterprise integrations, and business process transformation.
Exceptional verbal and written communication skills with the ability to communicate effectively at all organizational levels, including executive leadership.
Demonstrated experience managing stakeholder communications for complex, cross-functional enterprise projects.
Strong executive presence with the ability to influence without direct authority.
Excellent facilitation, negotiation, conflict resolution, and relationship management skills.
Experience managing third-party vendors and implementation partners.
Experience with Agile, Waterfall, and hybrid delivery methodologies.
Proficiency with Microsoft Project, Smartsheet, Jira, Azure DevOps, or similar project management tools.

Skill

PMP certification preferred. Experience with Adobe Sign or similar electronic signature platforms. Experience implementing workflow automation or low-code solutions.
Experience in Life Sciences, Pharmaceutical, or Clinical Trial environments. Familiarity with GxP or other regulated environments is preferred.

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Interested in this position? Send your resume to careers@xinthe.com.

Validation Engineer – Serialization (TraceLink Platform)

Role Summary:

We are seeking an experienced Validation Engineer with expertise in pharmaceutical Serialization and Track & Trace solutions, preferably the TraceLink platform, and at least 5 years of Computer System Validation (CSV) experience in the pharmaceutical or life-sciences industry. The role requires practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP computerized-system validation, and data integrity. The successful candidate should understand serialization processes, partner onboarding, system integrations, serial number management, EPCIS data exchange, regulatory reporting, and global Track & Trace requirements.

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Job Title: Platform Validation Engineer – Serialization (TraceLink)

Experience: 5+ yrs
Location: Hyderabad (Hitech City area)
Employment Type: Full-Time
Shift Time: 02:00 pm to 11:00 pm ( 5days WFO)

Key Responsibilities:

Plan, author, review, and execute CSV activities for GxP-regulated serialization and Track & Trace systems
Perform validation activities for TraceLink or equivalent serialization applications, interfaces, and related integrations
Develop, review, and maintain validation lifecycle documentation, including the following:
Validation Plans
User Requirements Specifications (URS)
Functional and Design Specifications
GxP and system risk assessments
Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) protocols
Test scripts and objective test evidence
Requirements Traceability Matrices (RTM)
Validation Summary Reports
Execute functional, integration, regression, and end-to-end validation testing for serialization systems and interfaces.
Validate serialization processes including serial number management, commissioning, aggregation, EPCIS data exchange, partner onboarding, regulatory reporting, and exception handling.
Apply risk-based validation and maintain traceability among requirements, risks, test cases, defects, and validation evidence.
Document and investigate validation deviations, test failures, defects, and discrepancies, and support their timely resolution.
Support system changes, upgrades, patches, enhancements, and integrations through established change-control and validation processes.
Maintain validation documentation in an inspection-ready state and support internal audits, external audits, and regulatory inspections.
Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, GxP, data-integrity requirements, and electronic-record/electronic-signature controls.

Serialization and TraceLink Competencies

Platform experience: Hands-on experience with pharmaceutical serialization solutions; TraceLink experience is strongly preferred.
Partner onboarding: Experience supporting onboarding and end-to-end testing across serialization networks and external partners.
Integration landscape: Experience validating data exchange between enterprise serialization platforms, packaging sites, 3PLs, CMOs or contract manufacturers, Marketing Authorization Holders (MAHs), and other supply-chain partners.
Serial number management: Knowledge of serial number provisioning to packaging lines, pools and ranges, and CMO/MAH-related processes.
Serialization events: Understanding of commissioning, decommissioning, aggregation, disaggregation, packing, unpacking, shipping, receiving, and related events.
EPCIS and troubleshooting: Ability to investigate interface failures, transaction errors, EPCIS issues, and data discrepancies.
Global requirements: Working knowledge of pharmaceutical serialization requirements across markets such as the United States, European Union, China, and Canada.

Mandatory Qualifications
Five years of relevant CSV experience in the pharmaceutical, biotechnology, or regulated life-sciences industry.
Hands-on experience with serialization or Track & Trace systems, with TraceLink exposure.
Strong practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP computerized-system lifecycle management, and data integrity.
Experience creating, reviewing, and executing validation documentation and risk-based test protocols.
Experience with requirements traceability, test evidence, validation deviations, defects, and change controls.
Strong documentation, analytical, troubleshooting, and stakeholder-communication skills.

Preferred Serialization Experience
Experience with Serialization / Track & Trace systems.
Hands-on TraceLink configuration, validation, partner onboarding, or end-to-end integration testing.
Experience with SAP ICH/ASN processes, EPCIS transactions, and message analysis.
Knowledge of GS1 serialization standards and packaging-line integration.
Experience with global serialization regulatory reporting.
Experience supporting serialization or Track & Trace implementations, upgrades, migrations, or enhancements.

Tools, Processes, and Collaboration
Experience using ServiceNow for RITMs or service requests, incident management, and change requests or change control.
Experience supporting deviations, Corrective and Preventive Actions (CAPAs), change controls, and production issues in a regulated environment.
Ability to collaborate effectively with Quality, IT, Packaging, Manufacturing, Supply Chain, Engineering, Automation, and external partners.

Skills:
Mandatory Qualifications • Five years of relevant CSV experience in the pharmaceutical, biotechnology, or regulated life-sciences industry. • Hands-on experience with serialization or Track & Trace systems, with TraceLink exposure. • Strong practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP computerized-system lifecycle management, and data integrity. • Experience creating, reviewing, and executing validation documentation and risk-based test protocols. • Experience with requirements traceability, test evidence, validation deviations, defects, and change controls. • Strong documentation, analytical, troubleshooting, and stakeholder-communication skills. Preferred Serialization Experience • Experience with Serialization / Track & Trace systems. • Hands-on TraceLink configuration, validation, partner onboarding, or end-to-end integration testing. • Experience with SAP ICH/ASN processes, EPCIS transactions, and message analysis. • Knowledge of GS1 serialization standards and packaging-line integration. • Experience with global serialization regulatory reporting. • Experience supporting serialization or Track & Trace implementations, upgrades, migrations, or enhancements.

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Interested in this position? Send your resume to careers@xinthe.com.

MES – IT Project/ Program Manager

Role Summary:

We are seeking a Project Manager to lead end-to-end delivery of MES implementation, upgrades, and enhancement projects in a GxP-regulated pharmaceutical manufacturing environment. This role owns the integrated project plan, cross-functional execution, RAID, governance, change control, and project financial/resource tracking, ensuring delivery is on-time, inspection-ready, and compliant with applicable regulatory expectations (including CSV and 21 CFR Part 11 awareness).

View Details

Job Title: Project/ Program Manager

Experience: 12+ yrs
Location: Hyderabad
Employment Type: Full-Time

Key Responsibilities (Non-Junior / Ownership Language)

Own end-to-end project deliveryfor MES implementations, upgrades, and enhancements, including execution planning through hypercare/handover.
Define and control scope: establish project objectives, deliverables, milestones, success criteria, and acceptance conditions with stakeholders.
Build and maintain the integrated project plan(workstreams, dependencies, critical path, resourcing), and drive adherence across teams.
Lead cross-functional executionacross Manufacturing, Quality, Validation, Engineering, Automation/OT, IT, and vendors/partners to deliver committed outcomes.
Own RAID management(Risks, Assumptions, Issues, Dependencies): proactively identify, quantify impact, drive mitigations, and escalate with clear options/recommendations.
Run governance and stakeholder communication:steerco/operating reviews, project meetings, decisions, minutes/actions, and executive-ready status reporting.
Own change control for project impacts:manage scope/timeline/cost changes, ensure approvals, and maintain decision traceability.
Plan and coordinate testing execution:UAT and system testing planning with SMEs, defect triage cadence, prioritization, and closure of critical defects.
Drive validation readiness in partnership with QA/Validation: ensure planning and delivery align to CSV lifecycle expectations and inspection-ready documentation standards.
Track project financials and resources:budget estimates, forecasting, variance analysis, and capacity planning; highlight risks early and propose tradeoffs.
Lead change management enablement:training coordination, readiness checkpoints, cutover/handover plans, and stabilization to operations/support.
Vendor & partner management (as applicable): manage timelines, deliverables, escalations, and performance against SOWs.

Required Qualifications (Project Manager, not Junior)

Bachelors degree in Pharmacy, Life Sciences, Engineering, IT, or Business Administration (or equivalent experience).
8+ years of experience in project management / IT delivery / manufacturing systems within pharma, biotech, medical devices, or other regulated environments.
Demonstrated ownership of integrated schedules, RAID, governance, change control, and delivery coordination across cross-functional teams.
Working knowledge of pharmaceutical manufacturing fundamentals and the realities of shop-floor execution (deviations, batch operations, constraints).
Practical understanding of SDLC (waterfall and/or Agile hybrid) and core PM disciplines (scope, schedule, cost, quality, comms).
Strong documentation discipline and ability to produce audit-ready artifacts (plans, minutes, decision logs, traceability, status packs).
Proficient with MS Office; experience with MS Project / Smartsheet / Jira strongly preferred.

Preferred Qualifications

Experience delivering or supporting MES platforms such as Rockwell PharmaSuite, Werum PAS-X, Syncade, Camstar, Opcenter, etc.
Experience with CSV concepts and deliverables (e.g., validation plans, requirements traceability, test protocols, summary reports) in GxP settings.
Strong familiarity with GMP / GxP, data integrity, and 21 CFR Part 11 expectations (awareness level is acceptable; deep SME not required).
Exposure to IT/OT interfaces, shop-floor connectivity, and manufacturing digital systems (e.g., LIMS, SCADA, historians, ERP integrations).

Key Skills

Project Planning & Scheduling (critical path, dependencies, resource loading)
RAID Management & Escalation
Stakeholder Management & Executive Communication
Governance & Status Reporting (SteerCo packs, decision logs)
Change Control / Scope & Timeline Management
Budget & Forecast Tracking (variance explanations)
Cross-functional Execution (Manufacturing/QA/Validation/IT/Engineering)
Regulatory Awareness (GxP/GMP/CSV; Part 11 awareness)
Testing Coordination (UAT, defect triage, readiness)

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Interested in this position? Send your resume to careers@xinthe.com.

Adobe Substance 3D Suite Specialist

We are looking for a highly experienced Substance 3D Suite Specialist with approximately 10 years of hands-on experience in 3D asset creation, materials, texturing, rendering, and product visualization to join the EasyVariants team. EasyVariants is a design automation platform that helps businesses create large volumes of accurate product variants from Adobe Illustrator artwork. The platform enables designers to automate variations in colors, logos, text, sizing, and other product attributes while maintaining visual consistency and brand accuracy.

In this role, you will be responsible for developing high-quality, photorealistic 3D product assets, materials, textures, and variant-ready workflows using the Adobe Substance 3D ecosystem. You will work closely with product, engineering, design, and 3D teams to establish scalable workflows that can support hundreds or thousands of product variations.

View Details

Job Title – Adobe Substance 3D Suite Specialist

Location – Visakhapatnam, Andhra Pradesh, IN

Experience – 8-15 years

Employment Type – Full-Time/ Permanent (WFO)

Key Responsibilities

1. 3D Asset & Product Visualization

Create and prepare high-quality 3D product assets suitable for EasyVariants workflows.
Develop photorealistic product visualizations for consumer products, apparel, footwear, accessories, packaging, lifestyle products, and similar categories.
Work with existing CAD, 3D models, scans, photographs, and 2D artwork to create production-ready 3D assets.
Ensure accurate geometry, proportions, UVs, materials, textures, lighting, and camera composition.
Prepare reusable 3D digital twins that can support multiple product SKUs and design variations.

2. Substance 3D Expertise

Demonstrate advanced hands-on expertise across Substance 3D Painter, Designer, Sampler, and Stager.
Create realistic and reusable PBR materials and procedural textures.
Build procedural material graphs and smart materials in Substance 3D Designer.
Use Substance 3D Sampler to create materials from photographs, scans, and real-world references.
Perform advanced texturing, masking, baking, decals, wear, imperfections, stitching, fabric, leather, plastic, metal, glass, paper, and other product surfaces.
Use Substance 3D Painter for high-quality texture authoring and material application.
Assemble, light, and render product scenes using Substance 3D Stager where appropriate.

3. Product Variant & Material Workflows

Develop workflows that allow rapid and consistent product color, material, texture, logo, pattern, and artwork variations.
Create parameterized/procedural materials that can be modified efficiently for multiple product variants.
Establish material libraries and reusable Substance assets for EasyVariants.
Ensure variations maintain consistent scale, placement, color accuracy, and visual quality.
Develop workflows for applying Adobe Illustrator artwork, logos, patterns, and graphics onto 3D products.
Work with UV layouts and texture coordinates to ensure precise placement of 2D artwork on 3D surfaces.
Support large-scale SKU generation and automated variant production.

4. Adobe Illustrator & 2D/3D Integration

Work extensively with Adobe Illustrator and Photoshop assets within Substance workflows.
Convert 2D artwork, vector graphics, patterns, labels, logos, and product designs into production-ready 3D applications.
Understand how Illustrator artwork can be mapped onto 3D models while preserving accurate positioning and proportions.
Collaborate with the EasyVariants team to define efficient 2D-to-3D workflows.
Troubleshoot artwork, UV, masking, material, and texture-mapping issues between Illustrator and Substance 3D. Adobe specifically supports workflows that bring Illustrator and Photoshop designs into Substance applications for realistic 3D visualization.

5. Automation & Scalable Workflows

Identify repetitive 3D production activities and develop approaches to automate or standardize them.
Work with developers/technical artists to integrate Substance workflows into EasyVariants’ automated product-variant pipeline.
Experience with Python scripting, Substance Automation Toolkit, APIs, batch processing, or procedural workflows is highly desirable.
Help define standardized naming conventions, folder structures, material libraries, texture formats, UV standards, and export specifications.
Develop processes capable of generating large numbers of product/material variations with minimal manual intervention.
Optimize workflows for quality, consistency, performance, and scalability. Adobe’s Substance ecosystem includes automation capabilities for batch processing assets, baking, and rendering, making automation knowledge particularly relevant to this role.

6. PBR & Material Quality

Strong understanding of Physically Based Rendering (PBR) principles.
Expert knowledge of maps such as:
Base Color
Roughness
Metallic
Normal
Height/Displacement
Ambient Occlusion
Opacity/Alpha
Ensure physically accurate material response under different lighting conditions.
Create optimized texture sets suitable for high-quality product rendering and downstream applications.
Maintain consistency between materials created from scans, photographs, and procedural techniques.

7. Quality & Production Standards

Establish quality standards for 3D assets, materials, textures, UVs, lighting, and renders.
Perform visual QA of generated product variants.
Identify and resolve issues such as texture stretching, UV distortion, incorrect color, material inconsistencies, geometry problems, and rendering artifacts.
Optimize 3D assets for both visual quality and production performance.
Document workflows, best practices, and technical standards for the wider 3D team.

Required Skills & Experience

Approximately 10 years of professional experience in 3D modeling, texturing, materials, product visualization, or digital asset production.
Advanced expertise in Adobe Substance 3D Painter, Designer, Sampler, and Stager.
Strong knowledge of PBR materials and physically based texturing.
Strong experience creating photorealistic product materials and textures.
Excellent understanding of UV mapping, baking, texture optimization, shading, lighting, and rendering.
Strong knowledge of Adobe Illustrator and Photoshop.
Experience converting 2D artwork/designs into realistic 3D product applications.
Experience with product visualization, e-commerce imagery, digital twins, or consumer-product rendering.
Strong understanding of 3D production pipelines and asset management.
Ability to create reusable, scalable, and parameterized materials.
Strong visual and technical problem-solving skills.
Ability to work with designers, developers, technical artists, and product teams.

Key Competencies

Expert-level Substance 3D knowledge
PBR & procedural material creation
Photorealistic product visualization
2D-to-3D artwork integration
UV mapping & texture optimization
Product variant generation
Procedural & automated workflows
3D asset pipeline development
Visual quality assurance
Technical problem solving
Cross-functional collaboration

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Interested in this position? Send your resume to careers@xinthe.com.

Adobe Illustrator Specialist

Role Summary

We are seeking a highly skilled Adobe Illustrator Specialist with deep expertise in creating professional vector graphics, technical illustrations, icons, infographics, and print-ready artwork. The ideal candidate should have extensive hands-on experience using Adobe Illustrator and be capable of creating scalable, high-quality visual assets for digital, print, marketing, engineering, or product documentation. The candidate should understand vector illustration principles, typography, color theory, layouts, and production workflows while maintaining high design standards.

www.xinthe.com (Our Parent company) www.easyvariants.com (Our Product)

View Details

Job Title – Adobe Illustrator Specialist / Vector Graphic Designer – Lead
Location – Visakhapatnam, Andhra Pradesh
Experience – 8-12 years
Employment Type – Full-Time (WFO)

Job Description:
Qualifications:

Bachelor’s degree in Graphic Design, Visual Communication, Fine Arts, Multimedia, or related discipline.
Equivalent professional experience will also be considered.
8–12 years of professional Adobe Illustrator experience.
Strong portfolio demonstrating advanced vector illustration skills.
Experience working on branding, technical illustrations, marketing creatives, or digital assets.
Experience working in an agency, design studio, product company, or enterprise environment.

Vector Illustration:

Create high-quality vector illustrations from concepts, sketches, images, or technical references.
Design scalable artwork suitable for print and digital platforms.
Create icons, logos, diagrams, technical drawings, and illustrations.
Convert raster images into clean vector graphics.

Graphic Design:

Design brochures, flyers, posters, banners, marketing collateral, and promotional materials.
Create infographics that communicate complex information visually.
Develop illustrations for presentations, reports, manuals, and websites.

Technical Illustration:

Produce technical illustrations for engineering, manufacturing, software documentation, or product manuals.
Create exploded views, isometric drawings, process flow diagrams, and schematic illustrations.

Production & Prepress:

Prepare print-ready files using CMYK, spot colors, bleeds, and crop marks.
Ensure artwork meets production and printing standards.
Optimize graphics for digital publishing.

Brand Compliance:

Follow brand guidelines across all creative assets.
Maintain consistency in typography, colors, layouts, and iconography.

Collaboration:

Work closely with UX designers, marketing teams, technical writers, product teams, engineers, and stakeholders.
Incorporate feedback and deliver revisions within project timelines.

Asset Management:

Organize Illustrator files and reusable graphic libraries.
Maintain templates, symbols, brushes, color palettes, and design assets.

Required Skills:

Adobe Illustrator (Expert):

Vector Drawing | Pen Tool mastery | Shape Builder Tool | Pathfinder | Live Paint | Image Trace
Gradient Mesh | Blend Tool | Clipping Masks | Compound Paths | Symbols | Artboards | Appearance Panel

Graphic Styles:

Layers Management | Perspective Grid | Pattern Creation | Custom Brushes | Typography
Color Management | Mesh Tool | Envelope Distort | Warp Effects | Transparency | Export Settings |

Design Skills:

Vector Illustration | Infographic Design | Icon Design | Logo Design | Layout Design
Typography | Color Theory | Composition | Visual Hierarchy | Brand Identity |

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Interested in this position? Send your resume to careers@xinthe.com.

IT Project Manager – MES

Role Summary:

View Details

Job Title: Project/ Program Manager

Experience: 12+ yrs
Location: Hyderabad
Employment Type: Full-Time

Key Responsibilities (Non-Junior / Ownership Language)

Own end-to-end project deliveryfor MES implementations, upgrades, and enhancements, including execution planning through hypercare/handover.
Define and control scope: establish project objectives, deliverables, milestones, success criteria, and acceptance conditions with stakeholders.
Build and maintain the integrated project plan(workstreams, dependencies, critical path, resourcing), and drive adherence across teams.
Lead cross-functional executionacross Manufacturing, Quality, Validation, Engineering, Automation/OT, IT, and vendors/partners to deliver committed outcomes.
Own RAID management(Risks, Assumptions, Issues, Dependencies): proactively identify, quantify impact, drive mitigations, and escalate with clear options/recommendations.
Run governance and stakeholder communication:steerco/operating reviews, project meetings, decisions, minutes/actions, and executive-ready status reporting.
Own change control for project impacts:manage scope/timeline/cost changes, ensure approvals, and maintain decision traceability.
Plan and coordinate testing execution:UAT and system testing planning with SMEs, defect triage cadence, prioritization, and closure of critical defects.
Drive validation readiness in partnership with QA/Validation: ensure planning and delivery align to CSV lifecycle expectations and inspection-ready documentation standards.
Track project financials and resources:budget estimates, forecasting, variance analysis, and capacity planning; highlight risks early and propose tradeoffs.
Lead change management enablement:training coordination, readiness checkpoints, cutover/handover plans, and stabilization to operations/support.
Vendor & partner management (as applicable): manage timelines, deliverables, escalations, and performance against SOWs.

Required Qualifications (Project Manager, not Junior)

Bachelors degree in Pharmacy, Life Sciences, Engineering, IT, or Business Administration (or equivalent experience).
8+ years of experience in project management / IT delivery / manufacturing systems within pharma, biotech, medical devices, or other regulated environments.
Demonstrated ownership of integrated schedules, RAID, governance, change control, and delivery coordination across cross-functional teams.
Working knowledge of pharmaceutical manufacturing fundamentals and the realities of shop-floor execution (deviations, batch operations, constraints).
Practical understanding of SDLC (waterfall and/or Agile hybrid) and core PM disciplines (scope, schedule, cost, quality, comms).
Strong documentation discipline and ability to produce audit-ready artifacts (plans, minutes, decision logs, traceability, status packs).
Proficient with MS Office; experience with MS Project / Smartsheet / Jira strongly preferred.

Preferred Qualifications

Experience delivering or supporting MES platforms such as Rockwell PharmaSuite, Werum PAS-X, Syncade, Camstar, Opcenter, etc.
Experience with CSV concepts and deliverables (e.g., validation plans, requirements traceability, test protocols, summary reports) in GxP settings.
Strong familiarity with GMP / GxP, data integrity, and 21 CFR Part 11 expectations (awareness level is acceptable; deep SME not required).
Exposure to IT/OT interfaces, shop-floor connectivity, and manufacturing digital systems (e.g., LIMS, SCADA, historians, ERP integrations).

Key Skills

Project Planning & Scheduling (critical path, dependencies, resource loading)
RAID Management & Escalation
Stakeholder Management & Executive Communication
Governance & Status Reporting (SteerCo packs, decision logs)
Change Control / Scope & Timeline Management
Budget & Forecast Tracking (variance explanations)
Cross-functional Execution (Manufacturing/QA/Validation/IT/Engineering)
Regulatory Awareness (GxP/GMP/CSV; Part 11 awareness)
Testing Coordination (UAT, defect triage, readiness)

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Interested in this position? Send your resume to careers@xinthe.com.

Batch IQ Engineer

Role Summary:

Develop and support an AI-powered document processing solution that automates data extraction from manufacturing batch records. The role includes designing and developing cloud-native applications on AWS, implementing OCR and Generative AI capabilities, integrating with enterprise systems, building user interfaces, ensuring application performance, security, and GxP compliance, and collaborating with QA, business, and validation teams throughout the software development lifecycle.

View Details

Job Title:

Batch IQ Engineer (Document Processing)

Experience: 10+ yrs
Location: Hyderabad (Hitech City area)
Employment Type: Full-Time

Key Responsibilities

Design, develop, and support AWS cloud-native applications for pharmaceutical manufacturing document processing.
Develop AI-driven solutions using OCR, Machine Learning, and Generative AIf or automated extraction and validation of data from batch records.
Build and integrate APIs and enterprise system interfaces to enable seamless data exchange.
Develop responsive and intuitive web-based user interfaces for document processing and data review.
Ensure application performance, scalability, security, data integrity, and reliability.
Implement solutions in compliance with GxP, 21 CFR Part 11, data integrity, and applicable CSV/validation requirements.
Collaborate closely with Business, QA, Validation, Manufacturing, IT, and other stakeholders throughout the SDLC.
Participate in requirements analysis, design, development, testing, deployment, troubleshooting, and production support.
Prepare and maintain technical documentation, validation evidence, and other SDLC artifacts.
Continuously improve AI/OCR accuracy, application performance, and document-processing workflows.

Required Skills

Strong experience in AWS cloud application development and cloud-native architectures.
Hands-on experience with OCR, Generative AI/LLMs, AI/ML, and document processing
Proficiency in modern programming languages such as Python, Java, or JavaScript/Type Script.
Experience with REST APIs, micro services, databases, and enterprise integrations.
Experience developing web applications/UI.
Good understanding of GxP, 21 CFR Part 11, CSV, SDLC, and data integrity principles within the Pharma/Life Sciences domain.
Strong problem-solving, communication, stakeholder management, and collaboration skills.

Preferred:

Experience with pharmaceutical manufacturing/batch records, MES systems, regulated AI applications, AWS AI services, and validated computer systems.

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Interested in this position? Send your resume to careers@xinthe.com.

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