GAMP jobs in Seattle, WA

Seattle, Washington

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Today

CSV EngineerJPC - 6850Costa Mesa, CA or Seattle, WA(On-site) Key Responsibilities:Develop and maintain Design Specifications (DS) for computerized and automated systems.Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.Generate and review validation reports and Validation Summary Reports (VSRs).Author and maintain Standard Operating Procedures (SOPs) for validated systems and equipment.Support implementation of CSV activities for IT and manufacturin

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Contract

Depends on Experience

Computer System Validation Engineer

Bothell, Washington

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Yesterday

Job Title: Computer System Validation Engineer Location: Bothell, WA (50% Onsite) Duration: 6 Months Work Type: Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution PURPOSE AND SCOPE OF POSITION: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, a

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Contract

$73 - $75

MES Engineer

Remote or Needham, Massachusetts

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12d ago

Title: MES Technical Consultant Regulatory Relevance: GxP The Role: The MES Technical Consultant will serve a key role owning the development and validation of core MES recipe objects and accompanying integrations. Additionally, this individual will also be well versed in Infobatch report development, web development, SQL, ISA S-95 standards will be act as an escalation point contact for the MES, Infobatch and ODH teams for complex initiatives. Key Responsibilities: Lead the design, development,

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Full-time, Third Party

$60 - $70

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

CSV Engineer

Bothell, Washington

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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

Staff Engineer - Software Quality - Indianola, Pa (Hybrid)

Remote or Indianola, Pennsylvania

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Today

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of br

Full-time

USD 97,264.00 - 145,897.00 per year

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Validation Engineer II

Remote or Durham, North Carolina

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Today

Job Description Summary The Validation Engineer II, assists with the authoring, executing and reviewing 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. Responsibilities:

Full-time

USD 70,000.00 - 130,000.00 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

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

PCS 7 Validation Engineer

Woodinville, Washington

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Today

Job Description: We are seeking a highly skilled and detail-oriented PCS 7 Validation Engineer to join our Automation/Validation team. This role will focus on developing and maintaining validation documentation for Siemens PCS 7 control systems within a regulated GxP environment. Your expertise will ensure compliance with FDA, EU, and GAMP 5 standards while supporting system readiness for production. Although primarily a documentation-focused position, you may also provide on-site execution sup

Full-time

Computer System Validation Engineer

Bothell, Washington

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Today

Job Description: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supp

Full-time

Controls Engineer (DeltaV)

Remote

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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

CSA Auditor, TraceLink

Remote

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11d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

Computer System Assurance

Remote

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26d ago

Location Remote (USA) Must Have Skills: Proven experience in CSA and GAMP 5 implementation.RTM configuration in any ALM tool, exposure to the Veeva CMS tools, need to have CSM admin experience.Strong knowledge of Veeva validation management and a basic understanding of Veeva configurations.Excellent analytical and problem-solving skills.Strong verbal and written communication abilities.Demonstrated ability to work effectively with global, virtual teams.Experience working independently, guiding

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Contract

$45+

Director - Lab Informatics

Remote

•

Yesterday

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

Director, Lab Informatics

Remote

•

Yesterday

Director, Lab Informatics Job Location- Remote Long Term 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, incre

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

Laboratory Information Management System (LIMS) Director

Remote

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2d ago

Role: Lab Informatics Location- Remote Duration: 12+ Month 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, increa

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Third Party, Contract

Depends on Experience

Business Analyst with Oracle Apex - Remote

Seattle, Washington

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Yesterday

Job Title: Business Analyst with Oracle Apex Location: Seattle WA (Remote) "Overview of Business Analyst Roles with Oracle Methodology Business Analysts (BAs) with expertise in Oracle methodologies play a crucial role in organizations by bridging the gap between business needs and technology solutions. They utlize Oracle applications to enhance business processes and ensure efficient operations. Must have Oracle Apex exp Key Responsible General Duties Analyze business processes and identi

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Contract, Third Party

MES Consultant

Bothell, Washington

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Today

Our client, a leading pharmaceutical company, is hiring a MES Consultant, on a contract basis. Job ID: 83492 Work Location: Bothell, WA - 50% on site Summary: The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade Manufacturing Execution System (MES). This role will support new product and process deployments as well as EBR revisions within the MES space in conjunction with several cross-functional de

Contract

Compensation information provided in the description

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GAMP jobs in Seattle, WA, USA