21 cfr part 11 jobs in san diego, ca

Remote

•

Yesterday

Job Role: Business Analyst -Pharma. Location: USA - Remote We are seeking an experienced Business Analyst with Pharma Domain expertise to bridge business and technology teams in delivering digital transformation, validation, data, and quality initiatives within regulated pharmaceutical environments. The candidate should possess strong knowledge of pharmaceutical business processes, GxP regulations, and requirements management, with experience working across manufacturing, quality, laboratory, s

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Full-time, Third Party

Depends on Experience

ML Platform Engineer

Remote or New York, New York

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14d ago

Role OverviewThis role will help enable algorithm development, model packaging, model registration, reproducible execution, and governed deployment workflows across imaging datasets, Integrated Data Products, and Analysis-Ready Datasets. The role is focused on ML platform engineering, MLOps, model integration, and validation readiness rather than developing new clinical interpretation algorithms. Key ResponsibilitiesBuild and support ML / MLOps capabilities within the Global Imaging Platform.Int

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Contract

Depends on Experience

Bioinformatics Pipeline Junior Test Engineer

San Diego, California

•

Today

Requirements: B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties. Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications. Familiarity with production software development lifecycle. Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD). bility to effectively communicate software system designs. Excellent communication skills (both written and

Full-time

Sr Engineer - Process Development

San Diego, California

•

Today

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role,

Full-time

USD 98,400.00 - 147,600.00 per year

Staff Enterprise Applications Developer - IBM Maximo

Remote or San Diego, California

•

Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 116,600.00 - 194,400.00 per year

Veeva Vault Analyst / Veeva Systems Administrator (CTMS & eTMF)

Remote

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4d ago

Veeva Vault Analyst / Veeva Systems Administrator (CTMS & eTMF) Remote Duration: 6-12 months Job Summary We are seeking an experienced Veeva Vault Analyst / Veeva Systems Administrator with strong expertise in Veeva Vault Clinical Suite, specifically CTMS (Clinical Trial Management System) and eTMF (Electronic Trial Master File). The ideal candidate will be responsible for administering, configuring, supporting, and optimizing Veeva Vault applications while collaborating with clin

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Contract, Third Party

Depends on Experience

Computer System Validation (CSV)

Remote

•

Today

We are looking for an experienced Computer System Validation (CSV) Consultant with strong experience in Life Sciences/Pharmaceutical domain. The ideal candidate should have hands-on expertise in validating GxP regulated systems, ensuring regulatory compliance, and supporting clinical and quality applications. Job Title: Computer System Validation (CSV) / Validation Consultant Life Sciences Location: Remote Duration: Long Term Must Have Skills 8+ years of experience in Computer System Validation

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Contract

Depends on Experience

Data Engineering Lead (Pharma OR LifeScience), 100% Remote

Remote

•

28d ago

Data Engineering Lead (Pharma OR LifeScience), 100% Remote 12-24+ Months Zoom or WebEx I need a highly technical person for this role. someone who can be hands on but also speak to customers/stakeholders. They must have experience with databricks, CTMS, GxP, 21 CFR Part 11 and a strong overall background in the life sciences and biopharma space. They need to have a project manager mindset as they will be client-facing. They dont need to be experts in site payments, just the info I men

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Contract

$90 - $100

Business Analyst

Remote

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26d ago

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, deliverin

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Contract

50 - 90

PASX Support engineer

Remote

•

7d ago

Bachelor's degree in Engineering, Computer Science, Information Systems, or equivalent practical experience. Proven hands-on experience configuring and maintaining Werum PAS X (MES) in pharmaceutical or biotech manufacturing environments. Strong understanding of pharmaceutical GMP, electronic batch records, and computerized system validation (CSV), including IQ/OQ/PQ documentation. Practical knowledge of MES concepts and standards (ISA 88, ISA 95) and how they map to PAS X configuration. Experie

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Contract

Depends on Experience

MES IT Coordinator

Remote

•

28d ago

Job TitleMES IT Coordinator / MES Application Support Lead (Manufacturing Execution Systems) Remote Job SummaryWe are seeking an experienced MES IT Coordinator to support the implementation, deployment, and ongoing support of Manufacturing Execution Systems (MES) within a regulated manufacturing environment. The ideal candidate will serve as the primary liaison between manufacturing operations, site IT, global MES teams, infrastructure, ERP teams, vendors, and offshore support teams to ensure su

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Contract, Third Party

60 - 70

Remote: ML Engineer (Image Processing/Life Sciences)

Remote

•

15d ago

Project:Global Imaging Platform Design & Build Role Overview This role will help enable algorithm development, model packaging, model registration, reproducible execution, and governed deployment workflows across imaging datasets, Integrated Data Products, and Analysis-Ready Datasets. The role is focused on ML platform engineering, MLOps, model integration, and validation readinessrather than developing new clinical interpretation algorithms. Key Responsibilities Build and support ML / MLOps

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Contract

Depends on Experience

ML Engineer

Remote

•

14d ago

Job Title: ML Engineer Location: Remote Duration: Long Term Rate: Best possible rate Project:Global Imaging Platform Design & Build Role Overview This role will help enable algorithm development, model packaging, model registration, reproducible execution, and governed deployment workflows across imaging datasets, Integrated Data Products, and Analysis-Ready Datasets. The role is focused onML platform engineering, MLOps, model integration, and validation readinessrather than developing new clin

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Contract

75 - 80

SAP ATTP Techno-Functional Consultant

Remote

•

6d ago

Employment type Contract Job Title SAP ATTP Techno-Functional Consultant Job Location Remote, Occasional Travel to Foster City, CA Duration 6 months Experience level L3 Mandatory Skills Job Description o Lead functional design, implementation, and optimization for ATTP-related programs and initiatives o Collaborate with business stakeholders & external partners (3PL, CMOs) to gather, analyze, and document functional requirements. Identify AS-IS process and design T

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Third Party, Contract

Depends on Experience

System Test and Validation Lead

Remote or Arlington Heights, Illinois

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6d ago

Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address emerging validation considerations for AI/ML-enabled systems and automation frameworks. If this sounds exciting, then this team may be the right fit for you! Work you'll do As a Senio

Full-time

USD 95,000.00 - 145,000.00 per year

Associate Director, Biostatistics & AI

Remote

•

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

SAP Delivery Manager (ERP) Life Sciences

Remote

•

Yesterday

SAP Delivery Manager (ERP) Life Sciences Devfi, Inc. 100% remote Salary: DOE About Devfi Devfi, Inc is an SAP services partner to life sciences and pharmaceutical companies. We deliver S/4HANA implementations for global pharma manufacturers, CDMOs, biotech and medical device clients across the Globe. Our clients operate under FDA, EMA and MHRA,GxP oversight. Every system we touch is validated and every change is auditable that standard is why they choose a specialist partner over a generalist.

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Contract

Depends on Experience

IT Business Analyst - Manufacturing Execution Systems

Remote

•

18d ago

Company Overview: Req ID: 380623 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. Job Description: Job Title Senior IT Business Analyst Manufacturing Execution System (MES) Project Overview Implement the OSCAR Manufacturing Execution System (MES) to enable Electronic Batch Records (EBR) along with Equipment Integration and OCPLM Integration for

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Contract, Third Party

$45 - $53.5

SAP Principal Architect, Transportation Management

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 pati

Full-time

USD 167,720.30 - 226,915.70 per year

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21 cfr part 11 jobs in San Diego, CA, USA