21 cfr part 11 jobs in atlanta, ga

Remote

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Today

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Contract, Third Party

Depends on Experience

Windchill Solution Architect/Senior Windchill PLM Consultant Medical Device Industry

Remote

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7d ago

Position Title: Windchill Solution Architect/Senior Windchill PLM Consultant Experience: 12+ Years Location: Flexible / Hybrid Domain: Medical Devices (additionally we can look at candidates from Life Sciences, Healthcare domain as well but preference shall be for candidates with Medical Devices domain background) Employment Type: Full Time / Contract Position Summary We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a

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Contract, Third Party

80 - 90

CQV Engineer

Atlanta, Georgia

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Today

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. uthor and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validat

Full-time

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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22d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

Technical Project Manager

Remote

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Today

Ideal Candidate Profile: 14+ years overall experience in software and data pipeline validation.8+ years managing technical projects in software, data, or infrastructure environments.Working knowledge of SDLC and Agile/hybrid delivery, plus hands-on experience with Jira, Confluence, or equivalents.Proficient with different AI technologies and LLMs.Ability to discuss architecture, integration, and security tradeoffs credibly with engineers.Strong written and verbal communication, including prepari

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Contract, Third Party

Depends on Experience

Clinical Data Analyst

Remote or New Jersey

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Today

Key Responsibilities: Develop, maintain, and execute SAS programs to support external data transfers, including validation against vendor transfer specifications Generate and maintain Data Review Listings (DRLs) and Study Health Metrics (SHMs) in accordance with study timelines Perform peer review of DRLs and data reconciliation reports Monitor automated job logs and resolve issues as needed Retrieve and post external vendor data using sFTP/FTP clients and vendor portals Collaborate with data ma

Full-time

Validation SME

Remote

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Yesterday

Validation SME- Remote Job Summary We are looking for an experienced Validation Subject Matter Expert (SME) with strong knowledge of pharmaceutical and life sciences validation processes, regulatory compliance, and quality systems. The candidate will provide technical expertise and leadership for validation activities across manufacturing, laboratory, utilities, and computerized systems. Key Responsibilities Lead and provide SME support for validation and qualification activities. Develop and

Full-time, Third Party

Depends on Experience

Product Owner

Remote

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21d ago

Role OverviewThe Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution.This role blends product management discipline with deep understanding of regulated clinical workflows, ensuring the platform delivers measurable value to sponsors, CROs, research sites, and patients. The PM drives feature development across study startup, patient identification, eligibility, randomiz

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Contract, Third Party

$80 - $85

Computer Vision Engineer

Remote

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4d ago

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

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Contract

Depends on Experience

Product Owner

Remote

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29d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

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Contract

Depends on Experience

Clinical Trial Product Owner

Remote

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18d ago

We are hiring for a Product Owner. It s a long-term contract role // Fully Remote role. Title : Product Owner Work Schedule: Fully Remote role. Required Skills : Product Owner with Pharma or Clinical Trial Platform Please email me your resume at Role Overview The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution. This role blends product owner discipline with deep

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Full-time

Depends on Experience

Windchill Solution Architect

Remote

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13d ago

Job Description: Summary Seeking an experienced Windchill PLM SME to assess the current PTC Windchill landscape and define the upgrade strategy and roadmap for Windchill 2027. Preference for candidates with a strong Medical Devices background; Life Sciences and Healthcare experience will also be considered. Responsibilities Assess existing Windchill configuration, customizations, workflows, data models, infrastructure, and integrations.Evaluate Windchill 2027 readiness, upgrade risks, technical

Contract

$100 - $130

Loftware Spectrum Technical Lead / Solution Engineer @ Remote

Remote

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22d ago

Position: Loftware Spectrum Technical Lead / Solution Engineer Location: Remote Duration: 6+ months Job Description: Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable g

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Contract, Third Party

Depends on Experience

Trackwise Digital Support Lead

Remote

•

Today

Job Position: Trackwise Digital Support Lead Job Location: Remote Job Duration: Fulltime Salary: $150K - $180K/Annum with benefits Job Description: Must Have Technical/Functional Skills: Strong relevant experience, including demonstrated L2/L3 support expertise for TrackWise / TrackWise Digital QMS in regulated life sciences or medical device environments.Hands-on expertise in TrackWise Digital support for global complaint handling, post-market support, complaints management and adverse event

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Full-time

Depends on Experience

Planisware PPM Administrator w/ Power BI

Remote

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Today

Global PMO Systems Specialist Location: 100%Remote - working hours EST Contract Duration: 12 Months plus Start Date: ASAP Compensation: Very attractive, won't be a waste time to discuss it. About the Role Our client is seeking an experienced Global PMO Systems Specialist to support its technical services organization within the pharmaceutical and life sciences industry. This position will serve as the primary Planisware System Administrator, with responsibility for platform configuration, go

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Contract

MLops Engineer (Remote)

Remote

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Today

Join TetraScience, the Scientific Data and AI Cloud company, as a Lead Software Platform Engineer working at the intersection of distributed systems and MLOps. In this role, you will own and scale AI and data infrastructure that supports production-grade AI/ML workflows for scientists at some of the world's largest pharmaceutical companies. This is a highly impactful opportunity for an engineer who has built AI/ML infrastructure as a multi-tenant product rather than internal tooling. You will s

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Full-time

$200 - $270

Sr. Clinical Developer/ SME (R+Clinical)

Remote or Hybrid in Tampa, Florida

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20d ago

Hi, Job DetailsPosition: Senior Clinical Developer/SME (R + Clinical)Location: Anywhere on the U.S. East CoastExperience Required: 8+ years of deep R programming experiencePrimary Skills: R, Pharmacokinetics (PK/PD), Clinical Data Processing, CDISC SDTM/ADaMKey Technologies: R Shiny, tidyverse, data.table, PKNCA, mrgsolve, rxode2Clinical Modeling Tools: NONMEM, Monolix, Phoenix WinNonlinReporting Tools: R Markdown, QuartoWork Arrangement: HybridRole OverviewWe are seeking an experienced Senior C

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Contract, Third Party

65 - 70

Reltio MDM Consultant

Remote

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4d ago

Lead Techno-Functional Reltio MDM Consultant Location: Raritan, NJ (Hybrid) Long term contract Key Responsibilities Strategic Leadership & Business Engagement Enterprise Stakeholder Management: Function as the primary onsite strategic liaison across IT, Data Governance, Commercial Operations, and Business Leadership to transform high-level business objectives into robust MDM blueprints. Domain Ownership & Governance: Design and govern the global master data roadmap for HCPs, HCOs, C

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Contract, Third Party

$5 - $30

Loftware Spectrum Technical Lead

Remote

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21d ago

Hello, We have an opening for the role mentioned below with Our client. Please review the job description and let me know if it aligns with your experience and interests. If so, kindly share your updated resume. Thank you. Loftware Spectrum Technical Lead / Solution Engineer Remote Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the prima

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Contract, Third Party

Depends on Experience

Workday Architect

Remote

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4d ago

looking for a Workday Solutions Architect. This will be a 9+ month contract. It is 100% remote. This will be highly vetted, references will be checked, and employment history verified. Workday Solutions Architect 100% remote Our client is seeking an experienced Workday Solutions Architect to lead a strategic assessment of migrating from SAP SuccessFactors to Workday. This role will evaluate the feasibility, business value, technical complexity, risks, and long-term implications of the propose

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Contract, Third Party

Depends on Experience

21 cfr part 11 jobs in Atlanta, GA, USA