GAMP Jobs in California

Refine Results
1 - 20 of 283 Jobs

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 13 days ago | Updated 10 hours ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

•

Walnut Creek, California, USA

Full-time

Job Description: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 1 day ago | Updated 10 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 17 days ago | Updated 10 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 12 days ago | Updated 10 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization. Responsibilities: Develop and execute Computer System Validation (CSV) de
Posted 17 days ago | Updated 10 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati
Posted 60+ days ago | Updated 10 hours ago

Automation Engineer

Katalyst Healthcares and Lifesciences

•

Thousand Oaks, California, USA

Full-time

Responsibilities: Manage day-to-day support of ATO Drug substance operations. Represent plant automation team in Area WCTs. Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports' adherence to Client training requirements. Represent Plant Automation team during the develo
Posted 60+ days ago | Updated 10 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 60+ days ago | Updated 10 hours ago

Senior Pharma GxP Project Manager with a strong background in SAP S/4 HANA validation

Pioneer Corporate Services Inc

•

Foster City, California, USA

Third Party, Contract

Job Title: Senior Pharma GxP Project ManagerLocation: Hybrid Foster City, CA (Locals or nearby states preferred)Duration: 12 Months Job Description:We are seeking a Senior GxP Project Manager with a strong background in SAP S/4 HANA validation and Life Sciences industries. The role demands excellent stakeholder and change management skills, hands-on validation expertise, and solid project leadership. Must-Have Skills: 15 20 years of overall experience 8+ years in Computer System Validation (CSV)
Easy Apply
Posted 8 days ago | Updated 7 days ago

SAP Finance FICO Consultant

URSI Technologies Inc.

•

Remote

Contract

SAP Finance FICO Consultant San Francisco, CA Remote Remote Qualifications The ideal candidate will have hands-on experience in SAP S4HANA and ECC, a strong understanding of GAMP 5, cGMP, and SOX compliance requirements, and proven application support skillsKey Responsibilities: Provide application support for SAP FICO modules within a regulated IT environmentTranslate business requirements into SAP solutions using SAP Best Practices, FIORI apps, and embedded analyticsJob description : 9+ to 15
Easy Apply
Posted 15 days ago | Updated 7 days ago

Workday Financials Architect

Datamatics Global Services, Inc.

•

Walnut Creek, California, USA

Contract, Third Party

Job Description: Workday Financials Architect Workday Financials Reporting Architect to lead the design and implementation of scalable, high-impact reporting solutions within their Workday Financial Management ecosystem. This role will partner closely with Finance, Accounting, and IT stakeholders to deliver actionable insights that drive data-driven decision-making. Key Responsibilities: Design and develop advanced financial reports and dashboards using Workday Report Writer, Composite Reports,
Easy Apply
Posted 16 days ago | Updated 5 days ago

Maintenance Technician

Radiant System, Inc

•

Fremont, California, USA

Contract

Description: Reporting Expectations: Onsite M-F 8-5, willingness to take weekend hours if needed TOP SKILLS PER MGR: 1) Willingness to work occasional off-hours to accommodate functional lab/business needs. 2) 2 years experience 3) lab equipment maintenance 4) at least 1 "desired" skill (GMP or HVAC) JOB DESCRIPTION: The Maintenance Technician is tasked with ensuring the proper functioning of various systems and equipment within a facility. This position entails performing routine maintenance,
Easy Apply
Posted 1 day ago

Manager-Strategic Sourcing and Supplier Management

NexInfo Solutions, Inc.

•

Foster City, California, USA

Contract, Third Party

About Nexinfo; NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges
Easy Apply
Posted 5 days ago | Updated 2 days ago

Staff Accountant Job with Highly Respected Non-profit Org.

Thor, Inc

•

Los Angeles, California, USA

Full-time

Staff Accountant Job with Highly Respected Non-profit Org. We are seeking an experienced accounting professional who wants to help people in need. Our client, a well-known and highly respected non-profit organization, is looking to hire a Staff Accountant on a full-time, direct hire basis. In this accounting position you will primarily be responsible for recording accounting transactions into the general ledger and reconciling the general ledger to the subsidiary ledgers/source systems. You will
Easy Apply
Posted 43 days ago | Updated 21 days ago

Full Stack Lead Engineer

Akshaya Inc

•

Remote

Contract

Job Description: Tech Stack: LAMP stack migration Node.js, Vue.js, CloudSQL, Google Cloud Platform Key ResponsibilitiesLead migration of legacy LAMP stack applications to modern Google Cloud Platform-based architectureBuild high-traffic, consumer-facing products from the ground upCollaborate with Product, QA, and Ops teams to align engineering effortsDesign and develop new products including prototyping and testingManage full product development life cycleIdentify and resolve technical issues to
Easy Apply
Posted 12 hours ago

Cost Financial Analyst

VIIS Global Inc.

•

San Jose, California, USA

Full-time

Job Description:We are seeking a Cost Financial Analyst to join our client s Finance team in San Jose, CA. The ideal candidate will have a strong background in accounting and cost analysis within the semiconductor industry. Key Responsibilities:Analyze and interpret large financial data sets under tight deadlines Develop revenue, manufacturing cost, and gross margin reports using standard cost Forecast variance and manufacturing spending accounts Improve Oracle system processes and automate reco
Easy Apply
Posted 36 days ago | Updated 29 days ago

Full stack Developer-LAMP

Akshaya Inc

•

Remote

Third Party, Contract

Job Title :LAMP Full stack Developer Location: Remote Experience: 15+Years Required Description: Lead efforts to build and migrate features from the current LAMP stack application to Google Cloud using state of the art techstack using NodeJs, VueJS, CloudSQL and Google Cloud technologies. Deep knowledge building full stack apps using VueJS, NodeJS, HTML5, CSS3, JavaScript and microservices. Working knowledge of PHP applications and ideally have experience migrating them.
Easy Apply
Posted 12 hours ago

Raw Materials Technical Specialist

Aditi Consulting

•

Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t
Easy Apply
Posted 2 days ago | Updated 4 hours ago

Assembler

Talent Groups

•

Compton, California, USA

Contract

Shift: 7:00 AM 3:30 PM Seeking a detail-oriented Assembler I to perform manual assembly of fiber and filtration products in a cleanroom environment.Responsibilities include assembling components, packaging, operating small tools, and following GMP and SOP guidelines.Ideal for candidates with 0 1 year of manufacturing experience; medical device background a plus.
Easy Apply
Posted 34 days ago | Updated 5 days ago

Process Engineer

Katalyst Healthcares and Lifesciences

•

Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.
Posted 59 days ago | Updated 10 hours ago