gamp Jobs in california

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DeltaV Automation Engineer

Fynbosys Inc

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Remote or Muskegon, Michigan, USA

Contract

Title : Sr/Lead DeltaV Automation Engineer Location - Muskegon, MI (Onsite) Cognizant JD : This is a remote position open to any qualified applicant in the United States.We are open to considering remote candidates who are willing to travel frequently to client sites at Muskegon MI. Travel Requirement : The travel requirements include an initial three weeks to overlap with another senior engineer. Subsequently, the schedule is anticipated to be two weeks of travel to Muskegon MI followed by thr
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Posted 1 day ago

compliance lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 1 day ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author 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
Posted 22 days ago | Updated 1 hour ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

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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 3 days ago | Updated 1 hour ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

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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 19 days ago | Updated 1 hour ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 14 days ago | Updated 1 hour ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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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 19 days ago | Updated 1 hour ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 1 hour ago

Automation Engineer

Katalyst Healthcares and Lifesciences

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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 1 hour ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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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 1 hour ago

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

Pioneer Corporate Services Inc

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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)
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Posted 10 days ago | Updated 9 days ago

SAP Finance FICO Consultant

URSI Technologies Inc.

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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
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Posted 16 days ago | Updated 8 days ago

Workday Financials Architect

Datamatics Global Services, Inc.

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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,
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Posted 18 days ago | Updated 7 days ago

Manager-Strategic Sourcing and Supplier Management

NexInfo Solutions, Inc.

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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
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Posted 7 days ago | Updated 4 days ago

Project Manager - Gxp

Oraapps Inc

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Remote

Contract

Job Title -Project Manager Gxp Location - Remote Contract Duration - 6+ Months Requirement: - 8+ years full lifecycle PM experience - Demonstrated PMLC/SDLC experience/success - Ability to quickly adapt to a maturing project environment - Ability to manage multiple concurrent priorities - MS Project and the ability to execute project plan is a must have MUST BE STRONG MS PROJECT - GXP & GMP Experience - Heavy experience required Plus: - GMP project experience, preferably as a PM - PMP certific
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Posted 1 day ago | Updated 5 hours ago

Staff Accountant Job with Highly Respected Non-profit Org.

Thor, Inc

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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
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Posted 44 days ago | Updated 23 days ago

Cost Financial Analyst

VIIS Global Inc.

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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
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Posted 38 days ago | Updated 31 days ago

Full stack Developer-LAMP

Akshaya Inc

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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.
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Posted 2 days ago

Raw Materials Technical Specialist

Aditi Consulting

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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
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Posted 3 days ago | Updated moments 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.
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Posted 36 days ago | Updated 7 days ago