Instrument Software Validation Analyst Job at NTT DATA (Cincinnati)

Instrument Software Validation Analyst

The Senior Software Quality Assurance is an advanced subject matter expert, acco...

Location

Belgium , Diegem

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science, Engineering, or Life Sciences
2–5+ years of experience in computer system validation (CSV) or software validation within a regulated industry (pharmaceutical, medical device, biotech)
Strong understanding of FDA, EMA, and GMP guidelines
Knowledge of laboratory information management systems (LIMS), chromatography data systems (e.g., Empower), and data integrity principles
Excellent technical writing and problem-solving

Job Responsibility

Document and validate software installed on lab instruments globally in accordance with EMA guidelines
Transition ongoing software management (Legacy SOP’s) to PPD IT software management SOPs
Document current-state software configurations and requirements
Gathering and documenting requirements
Authoring validation test cases
Developing software specifications
Creating infrastructure and data flow diagrams
Performing risk assessments
Create, execute, and document validation protocols (Installation Qualification/IQ, Operational Qualification/OQ, Performance Qualification/PQ) for laboratory and manufacturing instrument software
Generate validation plans, reports, User Requirement Specifications (URS), and traceability matrices to ensure compliance with 21 CFR Part 11, GAMP 5, and GxP standards

Fulltime

Murex Test Lead

Location

Singapore , Singapore

Salary:

Not provided

Randstad

Expiration Date

August 06, 2026

Requirements

Minimum 8–12 years of professional software testing experience operating strictly within corporate banking or capital markets environments
At least 5 years of hands-on experience with Murex (MX.3), demonstrating deep functional exposure across the trade lifecycle, risk components, and Datamart reporting modules
A proven track record leading testing teams and managing release gates on large-scale Murex implementations, version upgrades, or platform migrations
Strong structural understanding of capital markets financial instruments, including FX (Spot/Forward/Options), Interest Rate Derivatives, Equities, Fixed Income, or Credit products
Elite test management, defect tracking, and client-facing communication skills, with a proven ability to challenge and influence steering committees

Job Responsibility

Define, own, and execute the overall test strategy, master test plan, governance model, and delivery approach for complex Murex programs
Lead and govern end-to-end testing workstreams across System Integration Testing (SIT), User Acceptance Testing (UAT), automated regression, performance/stress testing, and dress-rehearsal cutover phases
Ensure all testing activities strictly comply with banking regulatory mandates, internal risk controls, and institutional security requirements
Oversee the end-to-end defect management lifecycle, running cross-functional triage forums to prioritize, track, and resolve system blocks across multiple workstreams
Partner closely with front/middle/back-office business stakeholders, integration developers, and Murex vendor teams to validate functional specifications and iron out environment discrepancies
Formulate and deliver crystal-clear testing status reports, quantitative quality metrics, burn-down charts, and proactive risk assessments to program and client leadership
Direct, resource, and mentor a team of dedicated QA stream leads and test analysts, enforcing consistent testing standards, automated script reuse, and delivery quality

Fulltime

Qc Validation Specialist

We are looking for an experienced QC Validation Specialist to join a leading-edg...

Location

Singapore , Singapore

Salary:

9000.00 - 9500.00 SGD / Month

Randstad

Expiration Date

July 19, 2026

Requirements

Minimum of a Diploma or Bachelor's Degree in any Engineering field, Science, or a related technical discipline
Minimum of 5 years of hands-on experience in the qualification, requalification, relocation, or decommissioning of GMP laboratory equipment within the pharmaceutical or biopharmaceutical industry
Demonstrated, deep familiarity with analytical and laboratory instrumentation (e.g., Chromatography systems, spectrometers, counters, and controlled temperature units)
Robust understanding of GMP regulations, data integrity principles, and data lifecycle management

Job Responsibility

Execute end-to-end qualification (IQ/OQ/PQ), requalification, relocation, and decommissioning/retirement protocols for a wide range of QC laboratory analytical and micro equipment
Lead validation activities for systems including, but not limited to: HPLC, CE, UV-Vis Spectrometers, TOC Analyzers, Microplate Readers, Liquid Particle Counters, Analytical Balances, Incubators, and Particle Counters
Author, review, and execute validation master plans, protocols, deviations, and final summary reports in strict accordance with Good Manufacturing Practices (GMP)
Collaborate closely with QC Lab Analysts, Quality Assurance, and external vendors to minimize lab downtime during relocation and equipment retirement
Ensure instrument software, audit trails, and historical data are securely backed up and compliant with data integrity standards prior to equipment decommissioning

What we offer

SGD 250 Monthly Transport Allowance

Fulltime

Software Development Senior Specialist

We are currently seeking a Software Development Senior Specialist to join our te...

Location

India , Noida

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Strong hands-on experience with LabVantage LIMS (v7.x / v8.x preferred)
In-depth knowledge of laboratory operations (QC, stability, sample management, batch release)
Experience with LIMS integrations (ERP, instruments, CDS, MES)
Fluent or professional-level German (spoken and written) – mandatory
Excellent English and German communication and documentation skills
Strong presentation skills with the ability to confidently interact with senior client stakeholders
Proven experience in client-facing roles or consulting engagements
Ability to manage multiple stakeholders and align business and technical teams
Strong analytical, problem-solving, and decision-making skills

Job Responsibility

Act as the primary client-facing Business Analyst for LabVantage LIMS engagements
Lead and facilitate requirements workshops, solution discussions, and stakeholder meetings in German and English
Build strong relationships with customer stakeholders across QC, QA, IT, and business teams
Clearly articulate solution designs, impacts, and benefits to non-technical audiences
Gather, analyze, and document business and functional requirements (URS, FRS, user stories)
Translate laboratory processes into LabVantage LIMS functional designs and workflows
Perform gap analysis and recommend best-practice solutions aligned with LabVantage capabilities
Support LIMS configuration including workflows, master data, and role-based access
Ensure all solutions comply with GMP, GxP, and data integrity principles
Support Computer System Validation (CSV) activities including URS, FS, IQ/OQ/PQ, and traceability matrices

Fulltime

Data Analyst CTI, B&W

Recognizing the increasing importance of digital in achieving our ambition, B & ...

Location

India , Mumbai

Salary:

Not provided

Unilever

Expiration Date

Until further notice

Requirements

Masters in Statistics, Biostatistics or equivalent (Data science, Mathematics or Statistics discipline)
Demonstrated expertise in applying statistical methods in scientific research
Experience of applying statistical Design of Experiments approaches
Hands-on technical expertise in data visualization
Strong technical background in multivariate statistical methods
Experience in data management using Python, R and Excel
Hands-on experience with professional statistical/modelling software such as SAS, Python, R, MATLAB and JMP
Strong interpersonal skills, oral and written communication skills
Ability to collaborate and consult effectively in teams
7–10 years of experience in data analysis, preferably within FMCG, Beauty category, Consumer Research, or R&D

Job Responsibility

Working together with the CTI Manager, to build data analytics programme to support B & W CTI team through the analyses of data, building and validating predictive models and interpretation and exploitation of analysis outcomes
Provision of statistics, data science expertise to deliver data analytics programme and build skills and capability of data analytics in B & W CTI teams
Consumer data analysis, consumer and technical data corelation and ML modelling
Engagement and collaboration with multi-disciplinary teams (Digital R & D, Formulation, Appraisal teams.)
Responsibility for the quality and defensibility of statistical analyses, models, and data interpretation
Engagement in continuous learning initiatives to keep abreast of state of the art analytical, statistical and machine learning methods
Analyse consumer research, sensory, usage & attitude, and clinical study data to generate actionable insights for product development and optimization
Integrate multiple data sources (consumer, clinical, instrumental, market) to build a holistic understanding of product performance
Identify patterns, drivers, and trade-offs between efficacy, sensorials, and consumer preference
Support claims development and substantiation through robust data analysis

Fulltime

Specialist IS Analyst

In this vital role, you will work as part of a Product Team focusing on the Elec...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering
Strong experience with enterprise application testing in GxP-regulated environments
Hands-on experience with CSV/CSA validation methodologies and documentation
Software engineering best practices: Git, CI/CD (Jenkins, Maven), automated testing
Experience supporting enterprise platforms with issue ticketing and customer-facing support models
Proven experience in Application Support & Maintenance (AMS) for regulated systems
Experience with cloud platforms (AWS, Azure, GCP)
Incident response experience, including P1/P2 production incidents
Experience with ServiceNow, ITIL processes, and change management workflows
Ability to translate vendor capabilities and constraints into business-aligned solutions

Job Responsibility

Work as part of a Product Team focusing on the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform, accelerating Amgen’s product development and commercial manufacturing
Collaborate with a dynamic, globally distributed team of technical product owners, business analysts, test/validation engineers, project managers, and scrum masters on the design, development, validation, support, and continuous optimization of Amgen Operations’ ELN ecosystem
Possess strong software development skills and rapidly translate concepts into working, production-ready solutions
Conduct code reviews to ensure quality, security, performance, and adherence to enterprise standards
Create and maintain documentation for architecture, design, validation, deployment, disaster recovery, and operations
Identify, troubleshoot, and resolve complex technical challenges across integrated enterprise platforms
Stay current with emerging technologies, industry best practices, and regulated system development trends
Lead and contribute to enterprise application testing in GxP environments, ensuring compliance with FDA, EMA, and global regulatory requirements
Own and execute CSV/CSA activities, including risk assessments, test strategy, IQ/OQ/PQ (or equivalent), traceability, and validation documentation
Develop and maintain test plans, test scenarios, and test scripts for system enhancements, patches, upgrades, and vendor releases

Clinical Outcomes Assessment Analyst

Clinical Outcome Assessment Analyst. ICON plc is a world-leading healthcare inte...

Location

United States , CARY, BLUE BELL, INDIANAPOLIS, MIAMI, TAMPA, DALLAS, HOUSTON

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master’s degree or PhD in psychology, psychometrics, biostatistics, health outcomes, or related field
Minimum 3 years of experience in COA development, validation, and/or application in clinical research (pharma, biotech, or CRO setting)
Strong understanding of FDA and EMA guidance on COAs and patient-focused drug development
Proficiency in psychometric methods and statistical software (e.g., SAS, R, Mplus, or similar)
Excellent written and verbal communication skills with ability to summarize complex data
Strong organizational skills and ability to manage multiple projects independently
Relevant drug development and/or commercialization experience within the pharmaceutical industry with strong knowledge of patient, regulator, and payer requirements
Significant demonstrated experience in developing and implementing strategies to apply scientific methods associated with the measurement, assessment and translation of the patient experience in multiple disease areas
Knowledge of the regulatory environment with particular knowledge of FDA Patient Focused Drug Development guidance, relevant guidance from other regulatory bodies, and evidentiary standards for Clinical Outcomes Assessment (e.g. PROs, ObsROs, ClinROs, PerfOs) label claims.

Job Responsibility

Execute and ensure the effective execution of work plans resulting in the development of relevant, reliable, and timely evidence for patients, regulators, clinicians, caregivers, and payers
Design and execution of research to inform COA strategy development
Develop and execute psychometric analysis strategy
Support clinical trial development for assigned programs, including relevant portions of protocols, statistical analysis plans, study reports, briefing books, and related documents
Identify gaps in available evidence needed to support fit-for-purpose use of COAs in a specified context
As needed, design and execute research to develop or modify COA instruments for inclusion in assigned programs
Consult on COA regulatory strategy
Create and oversee the creation of scientific materials that are submitted to regulators ensuring consistent quality
Develop publications of early COA research for disclosure in peer-reviewed journals and at scientific meetings
Ensure effective packaging of information and scientific materials for patients and caregivers for dissemination and disclosure

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Parttime

Senior Scientist I, Quality Control

This position is within the Quality Control structure, under the Quality Organiz...

Location

United States , Verona

Salary:

90000.00 - 108000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

M.S. in Chemistry (or related field) with 7+ years relevant laboratory experience
B.S. in Chemistry (or related field) with 9+ years of relevant laboratory experience
Fully knowledgeable of cGMP and ICH laboratory requirements and operations
Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices

Job Responsibility

Fully knowledgeable of cGMP requirements and ICH guidelines
Works independently to meet project timelines and deliverables with minimal supervision to no supervision
Collaborates routinely with Analytical Development on procedural method transfers and may participate in the execution of method validation protocols
Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and stability samples using established test methods and procedures
Proficient with various analytical instrumentation theory and practice
Executes training requirements for assigned SOPs and participates in department specific training modules
Independently completes complex instrumentation for testing according to written test methods and procedural documents to analyze samples
Demonstrates proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, and/or Raman spectroscopy) and will assist in training on instrumentation
Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization
Performs analyses in a timely and efficient manner to support ongoing prioritized studies

What we offer

competitive salaries and an excellent benefit package

Fulltime

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Instrument Software Validation Analyst

Job Description

Job Responsibility

Requirements

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