Clinical Data Validation Engineer Specialist Job at iconplc (Bangalore)

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

Engineering Technician

Engineering Technician position for a Medical Devices Company in Tempe, AZ. 6+ M...

Location

United States , Tempe

Salary:

18.00 - 22.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

0-3 years of experience
ability to follow instructions, collect data, record results
ability to operate lab equipment
Min High school diploma/GED
associates of science degree in technical discipline preferred

Job Responsibility

Product Builds: Assist, coordinate and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales
Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development
Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and test protocols which comply with GMP and Quality requirements
Test Method Development: Review test methods during test method development and assists with test method validations
Testing: Ability to perform tests by following instructions from development engineers
collect data and record test results
analyzing test data, organizing and presenting when it is necessary in a reportable format
Training: Provides process/test method training to manufacturing and QA personnel
Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule. Ensure equipment is operating properly. Obtaining quotes for testing and calibration
Materials/Inventory: generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking, shipping materials/receiving materials, preparing commercial invoices and liaising with internal Customs specialists

Fulltime

Clinical Development Specialist – Diagnostics

We are seeking an enthusiastic and detail-oriented Clinical Development Speciali...

Location

Malaysia; Singapore , Kuala Lumpur; Singapore

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, biomedical engineering, public health, or a related field
3+ years of experience in clinical development or clinical research, with a focus on diagnostics, in vitro diagnostics (IVDs), or medical devices
Familiarity with clinical validation and usability studies for diagnostics
Working knowledge of Good Clinical Practice (GCP), ISO 14155, and diagnostic regulatory frameworks
Strong organizational skills and the ability to manage multiple projects simultaneously
Excellent verbal and written communication skills
Highly skilled in stakeholder management across different regions and time-zones

Job Responsibility

Support the planning and execution of clinical studies—including analytical validation, clinical validation, and usability studies—aligned with diagnostic development goals
Assist in developing study protocols, investigator brochures, case report forms (CRFs), and other clinical study documents
Collaborate with internal stakeholders such as Regulatory Affairs, Clinical Operations, R&D, and Marketing to ensure integrated study planning and execution
Liaise with external investigators, clinical sites, and contract research organizations (CROs) to support effective study conduct and data integrity
Participate in data analysis and interpretation activities to support product development, regulatory submissions, and scientific communications
Track study timelines, milestones, and budgets to ensure clinical projects are completed on time and within scope
Maintain a strong understanding of diagnostic regulatory pathways (e.g., FDA, CE-IVD, CLIA) and ensure compliance with applicable clinical and ethical guidelines
Contribute to the development of abstracts, posters, and manuscripts to communicate clinical evidence to external audiences

Fulltime

Vice President, AI Enablement

The Vice President, AI Enablement leads Parexel’s enterprise‑wide Artificial Int...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

15+ years in data science, AI/ML, or technology leadership roles
at least 7 years in executive or senior leadership
Deep knowledge of clinical research processes, clinical data lifecycle, and pharmaceutical/life sciences regulatory expectations
Experience implementing enterprise AI platforms (GenAI, MLOps, data pipelines, automation)
Proven success operationalizing large-scale AI programs in GxP or other highly regulated industries
Familiarity with emerging AI regulations (EU AI Act, FDA, EMA expectations)
Experience with cloud-based AI ecosystems (Azure preferred)
Master’s degree or PhD in Computer Science, Data Science, Engineering, Bioinformatics, or related field preferred
Advanced business qualifications (MBA or equivalent) desirable
Excellent written and verbal communication skills

Job Responsibility

Define and evolve Parexel’s enterprise AI strategy, roadmap, and investment portfolio
Identify priority use cases aligned to business value, feasibility, and regulatory constraints
Conduct AI maturity assessments and establish long‑term capability-building plans
Co-chair AI governance
Define standards for model lifecycle management, validation, auditability, and transparency
Ensure compliance with GxP, global regulatory guidance, and responsible AI principles
Partner with Quality, Legal, and Compliance to operationalize risk management for AI systems
Oversee enterprise AI platforms, tooling, and data pipelines
Drive scalable architecture for GenAI, ML operations, retrieval‑augmented generation, and secure model hosting
Evaluate and integrate vendor platforms while ensuring data privacy and clinical-grade security

What we offer

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Opportunity to work on innovative projects at the forefront of the industry
Collaborative and inclusive work environment that values your expertise
Professional advancement and development opportunities

Fulltime

Specialist, GxP Compliance & Data Integrity

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Qua...

Location

United States , RTP, North Carolina

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
or Master’s degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Experience with supplier management program for computerized system suppliers
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance

Job Responsibility

Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance

Fulltime

AI Architect

Location

United States , New York, NY; Edison, NJ; Chicago, IL

Salary:

233000.00 USD / Year

Realign

Expiration Date

Until further notice

Requirements

Must have SI experience with larger IT service provider
10+ years of experience in software architecture or engineering, with at least 5+ years in AI/ML specifically
Proven experience designing and developing multi-agent AI systems in a production environment
Significant experience in the healthcare industry, with a deep understanding of clinical workflows, RCM, data standards (HL7, FHIR), and regulated environments
Expertise in multi-agent orchestration frameworks (e.g., LangChain, LangGraph, CrewAI, AutoGen)
Deep knowledge of LLM architectures, RAG implementation, and techniques for fine-tuning models
Extensive experience with cloud platforms (AWS, Azure, or GCP) and related AI services
Strong background in data engineering, including building ETL pipelines and managing vector stores
Proficiency in Python and relevant AI/ML libraries (e.g., PyTorch, TensorFlow)
Hands-on experience with MLOps practices and tools (e.g., Docker, Kubernetes, MLflow)

Job Responsibility

System architecture: Define the architectural vision and strategy for agentic AI solutions, designing end-to-end architectures that include model integration, orchestration frameworks, memory systems, and tool-use capabilities
Technical leadership: Guide and mentor cross-functional teams of AI engineers, data scientists, and DevOps specialists on architectural patterns and best practices for building scalable and reliable agentic AI systems
Cloud infrastructure and MLOps: Design and deploy multi-agent AI systems on cloud platforms (AWS, Azure, or GCP), building and managing cloud-native AI pipelines with MLOps best practices for monitoring, evaluating, and scaling agents
Healthcare integration: Lead the integration of agentic AI solutions with existing healthcare systems, and other enterprise platforms, while ensuring data interoperability and security
Responsible AI: Ensure the implementation of strong AI governance, security, and ethical practices throughout the agent lifecycle, including bias mitigation, fairness checks, and compliance with healthcare regulations like HIPAA
Proof of concept and scaling: Lead proof-of-concept (PoC) initiatives to validate new agentic capabilities, then develop strategies to scale successful prototypes into production-ready systems
Technology evaluation: Evaluate and integrate a wide range of open-source and proprietary AI tools and technologies, including vector databases, orchestration frameworks (e.g., LangChain, CrewAI), and cloud-native AI services
Thought leadership: Stay current with the latest advancements in agentic AI, generative models, and multi-agent frameworks, driving innovation within the company and potentially presenting at industry conferences

Fulltime

AI Architect

Location

United States , New York, NY / Edison, NJ / Chicago, IL

Salary:

233000.00 USD / Year

Realign

Expiration Date

Until further notice

Requirements

Must have SI experience with larger IT service provider
10+ years of experience in software architecture or engineering, with at least 5+ years in AI/ML specifically
Proven experience designing and developing multi-agent AI systems in a production environment
Significant experience in the healthcare industry, with a deep understanding of clinical workflows, RCM, data standards (HL7, FHIR), and regulated environments
Expertise in multi-agent orchestration frameworks (e.g., LangChain, LangGraph, CrewAI, AutoGen)
Deep knowledge of LLM architectures, RAG implementation, and techniques for fine-tuning models
Extensive experience with cloud platforms (AWS, Azure, or GCP) and related AI services
Strong background in data engineering, including building ETL pipelines and managing vector stores
Proficiency in Python and relevant AI/ML libraries (e.g., PyTorch, TensorFlow)
Hands-on experience with MLOps practices and tools (e.g., Docker, Kubernetes, MLflow)

Job Responsibility

System architecture: Define the architectural vision and strategy for agentic AI solutions, designing end-to-end architectures that include model integration, orchestration frameworks, memory systems, and tool-use capabilities
Technical leadership: Guide and mentor cross-functional teams of AI engineers, data scientists, and DevOps specialists on architectural patterns and best practices for building scalable and reliable agentic AI systems
Cloud infrastructure and MLOps: Design and deploy multi-agent AI systems on cloud platforms (AWS, Azure, or GCP), building and managing cloud-native AI pipelines with MLOps best practices for monitoring, evaluating, and scaling agents
Healthcare integration: Lead the integration of agentic AI solutions with existing healthcare systems, and other enterprise platforms, while ensuring data interoperability and security
Responsible AI: Ensure the implementation of strong AI governance, security, and ethical practices throughout the agent lifecycle, including bias mitigation, fairness checks, and compliance with healthcare regulations like HIPAA
Proof of concept and scaling: Lead proof-of-concept (PoC) initiatives to validate new agentic capabilities, then develop strategies to scale successful prototypes into production-ready systems
Technology evaluation: Evaluate and integrate a wide range of open-source and proprietary AI tools and technologies, including vector databases, orchestration frameworks (e.g., LangChain, CrewAI), and cloud-native AI services
Thought leadership: Stay current with the latest advancements in agentic AI, generative models, and multi-agent frameworks, driving innovation within the company and potentially presenting at industry conferences

Fulltime

AI Architect

Role: AI Architect

Location

United States , New York; Edison; Chicago

Salary:

233000.00 USD / Year

Realign

Expiration Date

Until further notice

Requirements

Must have SI experience with larger IT service provider
10+ years of experience in software architecture or engineering, with at least 5+ years in AI/ML specifically
Proven experience designing and developing multi-agent AI systems in a production environment
Significant experience in the healthcare industry, with a deep understanding of clinical workflows, RCM, data standards (HL7, FHIR), and regulated environments
Expertise in multi-agent orchestration frameworks (e.g., LangChain, LangGraph, CrewAI, AutoGen)
Deep knowledge of LLM architectures, RAG implementation, and techniques for fine-tuning models
Extensive experience with cloud platforms (AWS, Azure, or GCP) and related AI services
Strong background in data engineering, including building ETL pipelines and managing vector stores
Proficiency in Python and relevant AI/ML libraries (e.g., PyTorch, TensorFlow)
Hands-on experience with MLOps practices and tools (e.g., Docker, Kubernetes, MLflow)

Job Responsibility

System architecture: Define the architectural vision and strategy for agentic AI solutions, designing end-to-end architectures that include model integration, orchestration frameworks, memory systems, and tool-use capabilities
Technical leadership: Guide and mentor cross-functional teams of AI engineers, data scientists, and DevOps specialists on architectural patterns and best practices for building scalable and reliable agentic AI systems
Cloud infrastructure and MLOps: Design and deploy multi-agent AI systems on cloud platforms (AWS, Azure, or GCP), building and managing cloud-native AI pipelines with MLOps best practices for monitoring, evaluating, and scaling agents
Healthcare integration: Lead the integration of agentic AI solutions with existing healthcare systems, and other enterprise platforms, while ensuring data interoperability and security
Responsible AI: Ensure the implementation of strong AI governance, security, and ethical practices throughout the agent lifecycle, including bias mitigation, fairness checks, and compliance with healthcare regulations like HIPAA
Proof of concept and scaling: Lead proof-of-concept (PoC) initiatives to validate new agentic capabilities, then develop strategies to scale successful prototypes into production-ready systems
Technology evaluation: Evaluate and integrate a wide range of open-source and proprietary AI tools and technologies, including vector databases, orchestration frameworks (e.g., LangChain, CrewAI), and cloud-native AI services
Thought leadership: Stay current with the latest advancements in agentic AI, generative models, and multi-agent frameworks, driving innovation within the company and potentially presenting at industry conferences

Fulltime

Clinical Data Validation Engineer Specialist

iconplc

Location:
India , Bangalore

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 13, 2026

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