GAMP jobs in CA | Dice.com

Santa Clara, California

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Today

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As a Validation Engineer II, you will support validation and qualification activities for TruBio software and bioprocessing equipment. You will write and execute validation

Full-time

USD 72,000.00 - 108,000.00 per year

Validation Engineer III

Santa Clara, California

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Today

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As a Validation Engineer , you will lead validation and qualification work for TruBio software and bioprocessing equipment. You will own key validation deliverables, guide junior en

Full-time

USD 90,900.00 - 136,350.00 per year

Staff Validation Engineer

Santa Clara, California

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heights Job Description As a Staff Validation Engineer, you will play a key role in ensuring our bioprocessing equipment and TruBio software systems meet the highest st

Full-time

USD 112,500.00 - 187,500.00 per year

GXP Systems Validation Lead

Oregon City, California

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10d ago

GXP Systems Validation Lead Oregon City, California 12+ Months Job Description: Configuration Specialists and Tester Team (Leads) Determines validation approach, identifies deliverables needed or impacted by a project enhancement or change for GXP computerized systems and Infrastructure Responsible for the review of software documentation according to CSV corporateSOP39s, and regulatory guidance Provide estimates and forecast validation activities for a project Author validation plans reports,

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Third Party, Contract

Depends on Experience

Corporate Accountant

Hybrid in Palo Alto, California

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24d ago

Job Title: Corporate Accountant Location : Palo Alto ,CA In office 3 days/week Looking for a Corporate Accountant with around 7 years of experience. This person will be part of our close and assist with adhoc improvement projects. They should have worked at a software company. Must have experience with ASC 842 lease accounting and system experience with Leasequery and Netsuite. Strongly preferred experience is with debt accounting and cap software accounting. Strongly preferred system experience

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Contract, Third Party

Depends on Experience

Technical Accountant

Hybrid in Palo Alto, California

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22d ago

We are looking for Technical Accountant Position. Below is the Job Description, please have a look and if you are available for this position, please get back to me along with your updated resume in word format with contact number. Job Title: Technical Accountant Job location: Hybrid (Palo Alto, CA) Duration: 9 Months Contract Job Description: We are seeking a highly skilled Contract Accountant to provide experienced support to our accounting team. The ideal candidate will bring strong technica

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Contract

Depends on Experience

Principal SAP EWM Consultant

Foster City, California

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29d ago

Infosys is seeking a Principal SAP EWM Consultant This position requires an expert contributing to different phases of the consulting lifecycle. You will be intensely involved in business process consulting; you will define the problem, propose, and create the solution. You will also play an important role in the development, configuration, and deployment of the overall solution. You will guide teams on project processes, deliverables and contribute to the proposal development, client training a

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Full-time

$106,172 - $184,155

Accountant with CPA

Hybrid in Palo Alto, California

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3d ago

Job Title: Corporate Accountant Duration : 8 Months Location: Palo Alto CA, In office 3 days/week Looking for a Corporate Accountant with around 7 years of experience. This person will be part of our close and assist with adhoc improvement projects. They should have worked at a software company. Must have experience with compensation-related entries as a public company such as payroll, bonus, etc. and system experience with Netsuite. Strongly preferred system experience with Coupa and Blackli

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Contract

Depends on Experience

Computer System Validation Engineer 1

Remote

•

Today

Title: CSV Engineer 1 Location: Remote About: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems. Key Responsibilities Assist in the development and execution of validation documentation, inclu

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Contract

Director - Lab Informatics

Remote

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Today

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Sr. IT Program Manager

Remote or Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

USD 143,000.00 - 214,475.00 per year

Network Engineer - GxP/Regulated Environment

South San Francisco, California

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2d ago

We are seeking an experienced Network Engineer with strong hands-on expertise in Palo Alto, Cisco, and Meraki technologies to support and maintain secure, compliant network infrastructure within GxP-regulated environments for one of our clients in South San Francisco, CA. The ideal candidate will have a strong understanding of regulatory compliance requirements, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity, and experience operating under validated IT and quality systems.

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Contract

Depends on Experience

Sr Automation Engineer III

Foster City, California

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Today

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

Full-time

USD 182,070.00 - 235,620.00 per year

Senior CQV Engineer

Thousand Oaks, California

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Today

Job Summary : The Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment. This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements Roles & Responsibilities: uthoring, editin

Full-time

Senior Validation Engineer

Thousand Oaks, California

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Today

Job Description: This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements. The Senior Validation Engineer will act as a subject matter expert, collaborating closely with cross-functional teams, including Manufacturing, Facilities, Quality Control and Quality Assurance to deliver robust validation strategies that enable compliant and efficient

Full-time

Computer System Validation Analyst

Foster City, California

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Today

Summary : Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change management for existing qualified systems. Develop change management

Full-time

Sr. CSV Engineer

Oregon City, California

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Today

Summary : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

Validation Engineer III

Remote or Durham, North Carolina

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Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

AWS Infrastructure Qualification & Validation Specialist

Redwood City, California

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Today

Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices. Roles & Responsibilities: Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components. C

Full-time

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GAMP jobs in California, USA