21 CFR Part 11 jobs in Phoenix, AZ

Remote

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Today

Job Title: GenAI Evaluation Engineer Location: RemoteDuration: Long Term Required Qualifications:BS/MS in Computer Science, Statistics, Engineering, or a related field.2 5 years of experience in ML evaluation, QA engineering, or analytics, ideally in regulated domains.Proficiency in Python, pandas, and NumPy.Hands-on experience with evaluation libraries like NLTK, HuggingFace evaluate, and sacrebleu.Strong statistical rigor, with a deep understanding of metrics like Cohen s Kappa.Experience with

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Contract

Depends on Experience

Clinical Data Engineer/Analyst

Remote

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7d ago

Qualifications: Bachelor s or Master s degree in Computer Science, Data Engineering, Life Sciences, or a related field.3+ years of experience in data engineering, preferably within clinical research, pharma, or healthcare domains.Strong experience with ETL/ELT tools, data integration, and data ingestion pipelines.Proficient in SQL, Python, and/or Scala for data engineering tasks.Experience with cloud-based platforms such as AWS, Azure, or Google Cloud Platform, and tools like Databricks, Snowfla

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Third Party, Contract

Depends on Experience

Senior Clinical Data Manager

Remote

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22d ago

100% Remote Job Description Senior Clinical Data Manager Role Overview We are seeking an experienced Clinical Data Manager (CDM) to support multiple outsourced clinical studies. The ideal candidate will have strong hands-on expertise in EDC systems, data review activities, vendor data reconciliation, and CRO oversight. Responsibilities Manage 4 concurrent clinical studies outsourced to CROs, ensuring data integrity and compliance. Oversee day-to-day data review activities in the EDC, including

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Contract, Third Party

$50 - $90

Google Cloud Platform Auditor - IT SaaS

Remote

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21d ago

Education: Bachelor s degree in Life Sciences, Pharmacy, Chemistry, or a related field.Experience: Minimum 10+ years in Healthcare/Pharma QA, including 7+ years in Google Cloud Platform audit (preferably in SaaS platforms).Vendor Audits: Ability to assess third-party SaaS providers for compliance with contractual and regulatory obligations.Regulatory Knowledge: Strong expertise in ICH Google Cloud Platform E6, FDA, EMA, HIPAA, 21 CFR Part 11, and global standards. Experience working with clinica

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Contract

Depends on Experience

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

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23d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

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Contract

Depends on Experience

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

GenAI Evaluation Engineer

Remote

•

Today

Job Title: GenAI Evaluation Engineer Location: Hybrid/Remote Role Overview Your mission is to translate stakeholder needs from Regulatory, QA, and Data Science into rigorous, automated pipelines that guarantee model quality, safety, and regulatory compliance. Key Responsibilities Requirements & Test Plan Design:Run workshops with stakeholders to codify acceptance criteria for applications like CMC report analysis and patient-safety monitoring.Draft detailed test cases (both positive and negativ

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Contract

Depends on Experience

SAP ABAP Developer

Remote or Boston, Massachusetts

•

Today

Solution IT Inc. is looking for SAP ABAP Developer for one of its clients in Boston/Remote Job Title: SAP ABAP Developer Summary We are seeking an experienced SAP ABAP Developer to support and enhance SAP systems critical to our global medical device operations. This role will help deliver secure, compliant, and innovative SAP solutions aligned with business needs and SAP best practices, across manufacturing, quality, supply chain, and regulatory functions. The ideal candidate will bring techni

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Full-time, Contract, Third Party

SAP BTP Consultant

Remote

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9d ago

Job Role: SAP BTP Consultant Location: Memphis, TN Duration: 12+ months Role Description: Lead the design and delivery of enterprise integrations on SAP Business Technology Platform (BTP) with a primary focus on SAP Cloud Platform Integration (CPI/SAP Integration Suite).You will architect, implement, and govern integrations between SAP (S/4HANA/ERP/EWM/IBP/etc.), MOM/Manufacturing systems (e.g., Siemens Opcenter, Rockwell FactoryTalk), and ASRS/AGV ensuring secure, compliant, and highly availabl

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Contract, Third Party

Depends on Experience

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

Operational Technology (OT) Cyber Security Architect

Remote or Maryland

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Operational Technology (OT) Cyber Security Architect will serve as a senior authority driving the definition, composition, and implementation of security architectures across Thermo Fisher Scientific's manufacturing, laboratory, and R&D operations, as well as influencing the overall security of our enterprise corporate network. This role requires expertise in security principles and operations technology arch

Full-time

USD 143,000.00 - 190,600.00 per year

Systems Administrator

Remote or Tennessee

•

Today

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives

Full-time

Lead , Data & Platforms

Remote or Horsham, Pennsylvania

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Today

Full-time

USD 91,000.00 - 147,200.00 per year

Manager, Data & Platforms

Remote or Horsham, Pennsylvania

•

Today

Full-time

USD 100,000.00 - 173,500.00 per year

Principal SAP Architect, Enterprise Asset Management (EAM)

Remote

•

Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pat

Full-time

USD 154,142.00 per year

Quality Control Analyst-W2-Medical deivces

Remote

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12d ago

Title:QC Analyst Remote Design and configure analytical test methods in the EyeLab (LME) module of LabVantage LIMS. Collaborate with laboratory scientists and QA to translate SOPs and analytical procedures into executable LIMS workflows. Conduct method testing, validation, and troubleshooting in coordination with IT and LIMS administrators. Ensure all method executions comply with GMP, 21 CFR Part 11, and data integrity requirements. Prepare and maintain related documentation including URS, conf

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Contract

Depends on Experience

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

•

Today

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

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Full-time, Contract

BASED ON EXPERIENCE

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21 CFR Part 11 jobs in Phoenix, AZ, USA