GXP Jobs in San Jose, CA

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Technical Writer with GxP

Hireblox

Remote

Full-time

Job Title: Technical Writer Job Summary: Location: Remote (Eastern Time Hours) Job Type: Contract/ Hourly Full time 40 hours/week Duration: 6 months with high potential extension Responsibility for developing and revising procedures (Procedures, Work Instructions, Job Aides) with input from cross-functional teams, subject matter experts, and the Global Process Owners. This role requires a deep understanding of GxP practices, particularly in Document Management, and Learning Management systems. K

Benchling Technical Support Specialist (GxP / CSV Experience Preferred)

Infinite Computer Solutions (ICS)

Remote

Contract, Third Party

Job Summary: We are seeking a skilled and proactive Technical Support Specialist with hands-on experience supporting Benchling, a leading cloud-based platform for life sciences R&D. The ideal candidate will have a strong background in providing technical application support within a regulated GxP environment, and exposure to Computer System Validation (CSV) is highly desirable. The role requires close collaboration with the client s IT and Quality teams to ensure consistent and compliant system

Validation Lead

Radiansys, Inc.

Foster City, California, USA

Full-time

Validation Lead Foster City, CA 94404 (Onsite) FTE / CTH / Contract Job/ Role Description: Proven leadership in testing, validation for medium to large system implementations, ensuring GxP compliance and quality deliveryExtensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomesProficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reportingExpertise in HP ALM for managing testing cycles, with

Validation Lead

EA Team, Inc.

Foster City, California, USA

Contract, Third Party

We are in Critical need of Validation Lead for Long Term Contract in Foster City, CA Role : Validation LeadLocation : Foster City, CADuration : Fulltime HireJob Description : Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery.Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes.Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for p

Computer system Validation Engineer

Techim INC

Remote

Full-time

Benchling application support experience, along with GxP background, CSV experience will be added advantage.Provide first-line application support for Benchling users, resolving technical and functional issues.Troubleshoot errors across Benchling modules including Notebook, Registry, Inventory, and Workflows.Escalate complex issues to engineering or product teams with clear documentation.Support deployments and usage in validated GxP environments .

Director, IT

Abbott Laboratories

Santa Clara, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Are you ready to lead IT strategy and innovation in the Structural Heart business unit of Abbott's Medical Device Division? As the IT Business Partne

Senior AI Architect

MRoads

Remote

Contract

Required Skills: Proven experience in AI architecture and design, particularly with LLMs and AI agents.Strong understanding of GXP regulations and their application in AI solutions.Excellent communication skills to effectively collaborate with cross-functional teams.Ability to establish and enforce design principles that enhance user experience.

Veeva CRM Architect

Astrobyte Solutions LLC

Remote

Full-time

ob Title: Veeva CRM Technical ArchitectLocation: Remote Duration: Long term contract/ Full time Educational Qualification*Bachelor's or Master's degree in Computer Science, Information Technology, Engineering, or a related technical field. Additional certifications in Salesforce, Veeva CRM/Align are highly preferred.Job Description of Role* (RNR) (Mandatory - Minimum 500 words)Job Summary: We are seeking an experienced Veeva CRM Consultant with a strong background in Salesforce and Life Sciences

Benchling Technical Support Resource

Sierra Software Solutions

Remote

Contract

Hello Professionals, There's an open position at Sierra Software Solutions with one of our esteemed clients. If this role aligns with your experience and career aspirations, I d be happy to share more details and discuss it further. Please find the job description below. Role: Benchling Technical Support Resource Location: Bridgewater, NJ Work Remotely: Yes Required Skills: Experience with technical support for Benchling. Sector: Distribution Industry: CPG/Wholesale Thanks, Nagendar Nakka

Computer System Validation Specialist

SGS Consulting

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

AWS Solution Architect, Regulatory Strategy : : and USC

Srimatrix Inc.

Remote

Contract, Third Party

Role: Solution Architect, Regulatory Strategy location: Remote (EST Hours) **MUST HAVE Pharmaceutical Regulatory experience **AWS-Certified Solutions Architect certification required Education: BA/BS degree in a technical, engineering or scientific fieldAWS-Certified Solutions Architect certification requiredAWS Well-Architected Framework certification desirableAWS Certified Machine Learning Specialty certification desirable Experience and Skills: Required: Understanding of Pharmaceutical Regul

LIMS and QC Applications Consultant

Expedite Technology Solutions

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

Global Labeling Strategist

Sureminds Solutions

Remote

Third Party, Contract

Please share Profiles at Hi, Urgent need, Job Title: Global Labeling Strategist Work Location Remote C2C Requirement Global Labeling Strategist has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the Centralized, Mutual Recognition or Decentralized Procedure. Responsibilities: Drives labeling strategy in partnership with the Global

Senior Manager, Process Engineering

Gilead Sciences, Inc.

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

Trackwise Digital Architect

VeridianTech

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

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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

AI Engineer

Thermo Fisher Scientific

Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as an AI Engineer to implement innovative AI and ML methods for our GxP Quality Management System. Key Responsibilities: Build AI Solutions: Develop predictive models, anomaly detection systems, and LLMs to optimize QMS performance.Improve GenAI and LLMs: Apply Generative AI techniques and LLMs to automate and improve tasks like quality events analysis, document reviews, and complaint management.Work wit

Sr Manager, Data Sciences

Thermo Fisher Scientific

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

Specialist , IT/OT Technology Compliance (Hybrid - West Point, PA)

Merck & Company Inc

Remote or West Point, Pennsylvania, USA

Full-time

Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous matur

Senior Specialist , IT/OT Technology Compliance (Hybrid - West Point, PA)

Merck & Company Inc

Remote or West Point, Pennsylvania, USA

Full-time

Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuou