21 cfr part 11 Jobs in san jose, ca

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SS - Business Quality Assurance role

Apex 2000

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Remote or Indianapolis, Indiana, USA

Contract, Third Party

Hi Please sendin resume and ph# Business Quality Assurance (BQA) Location = Indianapolis, IN / remote Total Yrs. of Experience - 10-12 YEARS Relevant Yrs. of experience - 7 to 12 years Mandatory skills Strong knowledge in GMP, cGMP, regulatory standards (21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, ICH Q7) Experience in facing FDA audits associated with pharma manufacturing units Hands-on experience with manufacturing processes, CAPAs, deviations etc. Lead Auditor or any other compliance c
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Posted 60+ days ago | Updated 1 day ago

Computer Systems Validation Engineer

Corporate Solutions General, Inc.

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Remote or San Francisco, California, USA

Full-time, Part-time, Third Party, Contract

Computer System Validation Engineer (CSV) SFO, CA Onsite Contract Client : Cellares Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, an
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Posted 2 days ago | Updated moments ago

Systems Administrator / Technical Lead Process Control Systems

I.T. Solutions

•

Foster City, California, USA

Contract

Job Title: Systems Administrator / Technical Lead Process Control Systems Location: Foster City, Onsite (5 days a week) Duration: Long Term Contract 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 sy
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Posted 1 day ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 4 days ago | Updated 4 hours ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 15 days ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 4 days ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

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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Posted 30 days ago | Updated 11 hours ago

Sr. Reliability Engineer

Medtronic

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Remote or North Haven, Connecticut, USA

Full-time

We anticipate the application window for this opening will close on - 7 May 2025 Position Description: Sr. Reliability Engineer for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for development of reliability testing methodologies for electrical and mechanical components and subsystems, test methods, and validation activities to meet requirements. Interface with cross-functional group members, various suppliers, and test laboratories. Perform data analysis using sta
Posted 60+ days ago | Updated 4 hours ago

Trackwise Digital Architect

VeridianTech

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Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s
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Posted 60+ days ago | Updated 9 hours ago

Sr Manager, Data Sciences

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest inve