21 cfr part 11 jobs in atlanta, ga

Remote

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Today

We are seeking a Senior IT Project Manager with demonstrated experience leading complex, cross-functional technology initiatives in global and regulated manufacturing environments. The immediate priority for this role will be the delivery of projects involving Manufacturing Execution Systems, with a primary focus on the Critical Manufacturing MES platform. The successful candidate should also bring experience that can be applied across adjacent enterprise technology domains, such as SAP/ERP,

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Contract

60 - 65

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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28d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

MES Project Manager

Remote

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Today

Title: Sr Project Manager Location: Remote Duration: 6+ Months C2H We are seeking a Senior IT Project Manager with demonstrated experience leading complex, cross-functional technology initiatives in global and regulated manufacturing environments. The immediate priority for this role will be the delivery of projects involving Manufacturing Execution Systems, with a primary focus on the Critical Manufacturing MES platform. The successful candidate should also bring experience that can be applie

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Contract

Depends on Experience

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

SAP QM Consultant

Hybrid in Atlanta, Georgia

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23d ago

Job Title:Senior SAPQMConsultant Batch ManagementLocation:Atlanta, GA (Hybrid)About the RoleWe are looking for a highly experienced SAPQMConsultant with 15+ years of overall SAP experience and deep specialization in Batch Management to lead the design, configuration, and support of batch-managed material processes within SAPQM, integrated with SAP MM, PP, SD, and WM/EWM modules. This is a senior-level, hands-on role requiring both deep technical expertise and the ability to advise stakeholders

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Contract

Depends on Experience

SAP WM/ EWM Consultant

Hybrid in Atlanta, Georgia

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23d ago

Job Title:Senior SAPWM/EWM Consultant Batch ManagementLocation:Atlanta, GA (Hybrid) Experience:15+ Years Employment Type:ContractAbout the RoleWe are looking for a highly experienced SAPWM/EWM Consultant with 15+ years of overall SAP experience and deep specialization in Batch Management to lead the design, configuration, and support of batch-managed warehouse processes within SAPWM/EWM, integrated with QM, MM, PP, and SD modules. This is a senior-level, hands-on role requiring both deep techni

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Contract

Depends on Experience

Data Center Project Manager

Roswell, Georgia

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Today

Summary: This role is the day-to-day project lead for validated environment and laboratory construction projects (e.g., cleanrooms, biosafety cabinets, containment suites, biocontainment labs, and related utilities) across a campus. The Project Manager will report to the Project Executive and partner with Engineering, QA/Validation, Delivery, Sponsors, and regional leadership to deliver projects within a validated-state framework, focusing on operational excellence, compliance, and both tactica

Full-time

USD 115,000.00 - 170,000.00 per year

Lead LIMS Developer (SAPIO/LabVantage & Java)

Remote

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Today

Lead LIMS Developer (SAPIO/LabVantage & Java)Remote Full Time OverviewLead the architecture, development, and modernization of enterprise LIMS platforms using SAPIO/LabVantage, Java, and cloud technologies. Partner with laboratory and healthcare stakeholders to deliver scalable, secure, and compliant solutions. Key Responsibilities Lead architecture, design, development, and implementation of SAPIO LIMS and/or LabVantage.Translate laboratory requirements into workflows, integrations, and data mo

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Full-time

Depends on Experience

Business Analyst with Project Management (BA/PM)

Remote

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Today

Job Role: Business Analyst with Project Management (BA/PM) Location: Cambridge MA - Remote Mode: Long Term Project Job Required: We need emphasize on Gxp, CRO, Biotech, change requests, requirement traceability matirx, decommisioning applications, small projects , vendor management and stake holder management.10+ years of combined experience in Life Sciences IT, including:Minimum 5 years in a GxP-regulated system administrator or support capacity.Minimum 5 years in project management, delivering

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Contract

Depends on Experience

DeltaV Training Developer & Instructor

Remote

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Today

Position Overview: Develop and deliver a structured, Good Manufacturing Practice (GMP)-aligned DeltaV v16 Long-Term Support (LTS) training program for automation engineers and cross-functional stakeholders at a greenfield pharmaceutical manufacturing facility. Create site-specific learning content using the customers actual configuration, equipment, recipes, and DeltaV Live graphics. Deliver hands-on training in a DeltaV Simulate environment and support a train-the-trainer handoff so the custom

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Contract

Depends on Experience

Business Analyst with Clinical Trails _12+ Years Experience

Remote

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2d ago

Requirement details: Role: Business Analyst with Clinical Trails Location: Remote Duration: 12+ Months Job Description: 10+ Years of Experience The Business Analyst (BA) will serve as a key liaison between clients, product teams, clinical operations, and technical delivery teams. The BA will gather, analyze, and translate complex clinical trial requirements into functional specifications for eSource, DDC, and eCOA solutions. This role requires strong understanding of clinical trial processes, d

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Contract, Third Party

Depends on Experience

Werum PAS-X MES Lead / Solution Consultant

Remote

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Yesterday

Werum PAS-X MES Lead / Solution Consultant Location: Remote Duration: 9-12 month JD Skills- Werum PAS-X v3.18 or above MES, IOT,L2 systems 8-12 years of overall experience in Pharmaceutical Manufacturing, MES and other Digital Manufacturing solutions.Minimum 6+ years of hands-on experience in Werum PAS-X MES implementations, MBR designing,rollout and support.Strong experience in Pharma and Life Sciences manufacturing environments.Experience in global rollouts, MES deployments, upgrades, and go

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Contract

Depends on Experience

QA Test Lead

Remote

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Today

Senior QA / Test Lead DSI Integration / JD Edwards Remote workingJob Title: Senior QA / Test Lead DSI Integration / JD Edwards Experience: 10+ Years Domain: Healthcare / Life Sciences / Pharmaceutical Primary Skills: DSI Integration, Oracle, JD Edwards (JDE), MySQL, DSI MEP, Orchestrator Role Type: Testing / Quality Assurance / Integration Testing Position Summary We are seeking an experienced Senior QA / Test Lead with 10+ years of overall software testing and quality assurance experience, incl

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Contract, Third Party

Depends on Experience

Digital Engineer - POMS MES

Remote

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6d ago

Job Description: Role: Digital Engineer - POMS MES Location: Remote Duration: Long term Job Description Client is seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, enha

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Contract, Third Party

Depends on Experience

Project Manager- Life science industry

Remote

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30+d ago

Job Title: Project ManagerLife science industryLocation: Foster City, CA (Fully remote)Duration: FTEEducational Qualification*Any Bachelor''s DegreeExperience Range10 YearsTagline/Tech Stack Snapshot -PM with BA background and experienceRole Summary - (To be filled by Practice /DO)We are seeking a PM and Business Analyst with requirements gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating bu

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Full-time, Third Party

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Sr Mngr, Full Stack Clinical Platform Engineer

Remote or Almont, Colorado

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Today

Description: Remote Our client seeks a Full Stack Clinical Platform Engineer to design, implement, and operate production-grade Generative AI and Machine Learning solutions that support Global Development Digital Transformation. The role sits at the intersection of data engineering and applied AI. It partners with Clinical Operations, Data Management, Regulatory, and IT to build and maintain modern data platforms and AI-enabled pipelines that underpin the transformation program. The position r

Contract

Validation Lead-Remote

Remote or Raritan, New Jersey

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Today

Role: Validation Lead Location: Raritan, NJ(Hybrid) Duration: 6+ Months Job Description: Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment

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Contract

Associate Director, Biostatistics & AI

Remote

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Today

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare dis

Full-time

USD 173,800.00 - 217,000.00 per year

Associate Director, RBQM Data Enablement and Analytics

Remote or Massachusetts

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Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Accountabilities: Configure Centralized Monitoring platform, including DQA, QTLs and KRIs, to identify and manage critical study risk

Full-time

USD 154,400.00 - 242,550.00 per year

Solutions Engineer, Life Sciences

Remote

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Today

Who we are At Domino, we build software that helps the largest, AI-driven organizations build and operate advanced data science and AI solutions at scale. Our platform integrates a streamlined model development environment, MLOps capabilities, and novel features for collaboration, reuse, and reproducibility - all of which make data science teams more productive, reduce time to value, and ensure compliance. Our customers - like Johnson & Johnson, GSK, Bristol Myers, UBS, FINRA and the US Navy -

Full-time

USD 160,000.00 - 230,000.00 per year

21 cfr part 11 jobs in Atlanta, GA, USA