fda Jobs in california

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CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

•

San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 24 days ago | Updated 2 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 24 days ago | Updated 2 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 24 days ago | Updated 2 hours ago

Validation Engineer

Zachary Piper Solutions, LLC

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Lynwood, California, USA

Full-time

Piper Companies is currently seeking an experienced Validation Engineer tosupport a highly reputable Pharmaceutical company in Lynwood, California. Responsibilities for the Validation Engineer Oversee validation activities, including risk analysis, packaging, cleaning, and equipment qualification for new and updated processes.Develop, review, and execute validation protocols, reports, and documentation while ensuring compliance with GMP standards.Coordinate validation efforts across shifts, pr
Posted 8 days ago | Updated moments ago

Oracle Field Service Cloud Consultant

Prutech Solutions

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Remote

Contract

Job Title: Oracle Field Service Cloud Consultant Duration: Full Time / Contract Location : Remote Required Skills/Experience: Bachelors degree in computer science, Information Technology, Engineering, or a related field.5+ years of experience in implementing and supporting Oracle's Field Service solutions.Strong understanding of and field service processes and best practices.Proven expertise in Oracle's E-Business Suite, Cloud, or other relevant Oracle products.Excellent analytical and problem-
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Posted 51 days ago | Updated 1 day ago

SAS Programmer

Katalyst Healthcares and Lifesciences

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San Diego, California, USA

Full-time

Responsibilities: Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I- clinical studies. Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS. Create and review annotated CRF to STDM datasets. Produce and maintain technical programming specification documents. Lead and actively participate in client and project review meetings.
Posted 15 days ago | Updated 2 hours ago

Engineer II, Quality Compliance

Masimo Corporation

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Irvine, California, USA

Full-time

Job Description Job Summary The Senior Engineer, Quality Compliance will be responsible for the specific area of Analysis of Data in the Quality Compliance department. This position will interface with representatives from different departments within the organization (e.g. Quality Compliance, Quality Assurance, Engineering, and Operations) to prepare metrics for routine quality reviews and management reviews. This individual will also be responsible for assisting in the development of new pro
Posted 2 days ago | Updated 2 hours ago

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w
Posted 8 days ago | Updated moments ago

Quality Engineer I

Judge Group, Inc.

•

Lake Forest, California, USA

Full-time

Location: Lake Forest, CA Salary: $34.00 USD Hourly - $35.00 USD Hourly Description: Position Title: Quality Engineer I Duration: Contract Work Location: Irvine, CA The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk
Posted 40 days ago | Updated 11 hours ago

Director, Biocompatibility Engineering R&D

ICU Medical, Inc.

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San Diego, California, USA

Full-time

Job Description Position Summary The Director of Biocompatibility Engineering will lead the centralized development, implementation, and oversight of biocompatibility programs for ICU Medical's global medical devices. The role will be responsible for overseeing the biocompatibility assessment and testing for all new and existing products. This individual will ensure that all products meet regulatory standards and guidelines related to biological safety and compatibility, particularly the EU Med
Posted 3 days ago | Updated 2 hours ago

IVD Systems Engineer

Tranzeal, Inc.

•

Santa Clara, California, USA

Contract

Job Title: Senior Systems Engineer Location: Santa Clara, CAOnsite Position Summary: This Senior Systems Engineer will be part of the System Development team focusing on the development of client's IVD automated systems and end-to-end product solutions. The individual is expected to provide technical and process expertise in collaboration with internal stake holders and cross functional teams throughout total product development lifecycle to develop and maintain medical device products, accordin
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Posted 4 days ago

Principal Product Security Engineer (REMOTE)

Stryker

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Remote or Portage, Michigan, USA

Full-time

Work Flexibility: Remote Product Security is driven to make healthcare better by ensuring that Stryker designs, develops, and maintains industry leading cyber secure products for our customers. We are seeking a highly skilled Secure Product Lifecycle Expert to ensure the security of our medical devices across their entire lifecycle. This role is critical in embedding robust security practices into our software development lifecycle (SDL), overseeing post-market security management, and integrat
Posted 7 days ago | Updated 2 hours ago

Software Quality Engineer

Masimo Corporation

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Irvine, California, USA

Full-time

Job Description Job Summary: The Software Quality Engineer for Medical Device is responsible for ensuring the quality, reliability, and compliance of software used in medical devices. This role involves developing and implementing software quality assurance processes, conducting rigorous testing, and collaborating with cross-functional teams to identify and resolve defects. The engineer will also ensure adherence to regulatory standards and industry best practices, perform risk analysis, and c
Posted 2 days ago | Updated 2 hours ago

SAP Financial Consultant

Beacon Systems, Inc

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Remote

Contract

Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. We are looking for an SAP Financial Consultant - Remote Request you to make sure your updated Resume highlights all the
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Posted 5 days ago | Updated 2 days ago

SAP Supply Chain Consultant

Saksoft

•

Sunnyvale, California, USA

Contract, Third Party

Job Description: Seeking a highly skilled and experienced SAP Manufacturing/Supply Chain Consultant to join our team in Sunnyvale, CA. In this role, you will be responsible for the design, configuration, implementation, and support of SAP solutions related to manufacturing, supply chain planning, and execution. You will work closely with our manufacturing, supply chain, and operations teams to optimize our production processes, improve efficiency, and ensure seamless flow of materials. The ideal
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Posted 10 days ago | Updated 10 days ago

Systems Administrator / Technical Lead - Process Control Systems

Katalyst Healthcares and Lifesciences

•

Foster City, California, USA

Full-time

Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates
Posted 24 days ago | Updated 2 hours ago

PeopleSoft Change Management / Training Consultant

Beacon Systems, Inc

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Remote

Contract

Hello, I hope this mail finds you well. About Radiant Digital, Inc Radiant Digital, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Services. We have a vast portfolio of clients across the country. Our Technology supports many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwid
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Posted 4 days ago

Human Factors Lead

Apidel Technologies

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Remote

Contract

Human Factors Lead (Fully remote job) Job Description: Reporting to the Medical affairs (MA), this role defines work roles and oversees human factors, user experience, and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develop projects as part of business goals and associates are compliant in following procedures. The Senior Manager will lead a Human Factor reviews and all related activity inclu
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Posted 17 days ago | Updated 16 days ago

Senior Program Manager

Value Connect Corp

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Remote

Contract

Job Description: We are seeking a highly experienced and strategic Senior Program Manager to lead cross-functional programs across business and manufacturing operations. This role will focus on driving transformation initiatives, operational excellence, and technology integration (e.g., Industry 4.0, lean manufacturing). The ideal candidate brings deep manufacturing expertise, exceptional leadership, and a track record of delivering complex, high-impact programs. Key Responsibilities - Lead an
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Posted 1 day ago

Product Owner

Tandym Tech

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Remote

Contract

A leading organization in Washington, D.C., is looking to hire an experienced Product Owner for a Remote, contract role. As a Product Owner, you'll collaborate across technical and business teams to drive product strategy, streamline backlogs, and deliver top-tier functionality that supports organizational growth and innovation. This is an exciting opportunity for a strategic and innovative thinker who thrives in Agile environments and can transform business goals into actionable roadmaps. Abou
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Posted 22 days ago | Updated 3 hours ago