GAMP jobs in Newark, DE

Wilmington, Delaware

•

Today

Hi, Title:Computer System validation Engineer Compute System Validation(CSV) with R&D Knowledge Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic r

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

Business Analyst, AI & Enterprise Data Products with Pharma domain exp + Google Cloud Platform environment exp

Remote

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9d ago

Business Analyst, AI & Enterprise Data Products with Pharma domain exp + Google Cloud Platform environment exp Duration: 12+ Months Location: Remote Work Authorization: USC Position Summary We are seeking a Business Analyst to define requirements for an AI-driven application serving internal business functions across Quality / Manufacturing / Clinical / Regulatory / Commercial. The application sits on top of a substantial data layer, drawing from multiple enterprise source systems, and uses m

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Contract

60 - 65

Computer System Validation Engineer

Wilmington, Delaware

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Today

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time

Director, Global Digital & Technology Systems

Remote

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Today

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: BeOne Medicines Global Research and Development Technology Solutions (GRDTS) team is seeking a motivated, enthusiastic, and experienced Digital & Technology Systems Direc

Full-time

USD 172,500.00 - 232,500.00 per year

Senior Automation Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Role requires a senior level automation engineer comfortable operating independently while supporting others. No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution. DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing Strong troubleshooting and problem solving skills in live manufacturing environments, including commissioning, issue triage, and rapid resolution under GMP constr

Full-time

SAP Delivery Manager (ERP) Life Sciences

Remote

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27d ago

SAP Delivery Manager (ERP) Life Sciences Devfi, Inc. 100% remote Salary: DOE About Devfi Devfi, Inc is an SAP services partner to life sciences and pharmaceutical companies. We deliver S/4HANA implementations for global pharma manufacturers, CDMOs, biotech and medical device clients across the Globe. Our clients operate under FDA, EMA and MHRA,GxP oversight. Every system we touch is validated and every change is auditable that standard is why they choose a specialist partner over a generalist.

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Contract

Depends on Experience

CSV Engineer

Newark, Delaware

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Today

Job Summary: We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle. Roles & Responsibilities: Lead and support CSV activities for GxP systems, in

Full-time

GAMP jobs in Newark, DE, USA