Gamp jobs in summit, nj

Hybrid in Raritan, New Jersey

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4d ago

Role CSV Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standa

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Contract

Depends on Experience

CSV Lead

Hybrid in Raritan, New Jersey

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Today

Job Title: CSV Lead Location - Raritan, NJ (Hybrid) W2/C2C Mandatory Skills - LIMS Lab Vantage & CSV Job Summary: Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related 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 guidances and industry standards (i.e., GAMP) Experience in writing and executing documentation for all as

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Contract, Third Party

55 - 60

Equipment Engineer

Summit, New Jersey

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Today

Job Summary: The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment. The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal t

Full-time

CSV Consultant(Computer System Validation ? GenAI, Agentic , SAP

Raritan, New Jersey

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Today

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Contract

USD45.0/HOURLY - USD52.0/HOURLY

CSV Lead

Hybrid in Raritan, New Jersey

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Today

About Us: CodeForce 360 is a trusted global IT talent partner helping Fortune 500 companies, system integrators, and enterprise organizations build high-performing technology teams. With over 16 years of industry expertise, we combine speed, precision, and market intelligence to deliver exceptional talent across today's most in-demand technologies. About the Job- We are looking for an experienced CSV Lead to join one of our enterprise client engagements. The ideal candidate should have st

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Contract, Third Party

$47 - $52

Senior Director, Information Technology (BioPharma Industry)

Morristown, New Jersey

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Today

Description The Senior Director, Information Technology will lead enterprise technology strategy, infrastructure, cybersecurity, GxP validation, SOX compliance, and the business application roadmap for a growing late-stage clinical biopharmaceutical organization transitioning toward commercialization. This role will architect scalable technology capabilities, establish practical governance, and align IT with business objectives. The leader will manage a small internal IT team, oversee managed s

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Full-time

USD 210,000.00 - 255,000.00 per year

CSV Consultant

Hybrid in Raritan, New Jersey

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20d ago

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida

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Contract

45 - 50

Lead Engineer

Hillsdale, New Jersey

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Today

At E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining, Warehousing & Distribution, and CPG/Food & Beverage industries. Our national scale allows us to help our clients develop and implement standardized solutions

Full-time

Staff Automation Engineer

Raritan, New Jersey

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 94,000.00 - 144,500.00 per year

Computer Systems Validation Engineer

Remote

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Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 per year

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

Remote

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10d 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

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

CSV Lead, Hybrid - 69811

Raritan, New Jersey

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Today

CSV Lead, Hybrid We have an immediate need for an experienced CSV Lead with strong expertise in LIMS LabVantage, Computer System Validation (CSV), GxP standards, and risk-based validation to lead validation activities within a regulated Pharmaceutical or Biotechnology environment. This is a hybrid position based in Raritan, NJ for a candidate with deep experience in LIMS LabVantage, CSV, FDA/GxP regulated environments, GAMP, validation planning, requirements documentation, compliance/validation

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Contract

$50.00 - 55.00

CSV Validation Lead

Hybrid in Raritan, New Jersey

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5d ago

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Contract

Depends on Experience

SAP Delivery Manager (ERP) Life Sciences

Remote

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28d 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/Validation Consultant

Raritan, New Jersey

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4d ago

Role - CSV Consultant Location - Raritan, NJ (Hybrid) Three combination for three different roles (Any combination will work) 1) with SAP & Gen AI 2) with M&A 3) Annex 11 Remediation Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.Demonstrated delivery experi

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Contract, Third Party

Depends on Experience

Gamp jobs in Summit, NJ, USA