GAMP jobs in Summit, NJ

Commissioning, Qualification, and Validation (CQV) Engineer

Edison, New Jersey

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Today

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Full-time

Equipment Engineer

Summit, New Jersey

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14d ago

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

Computer Systems Validation Engineer

Remote

•

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

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Sr. Computer Systems Validation Engineer

Remote or Trumbull, Connecticut

•

Today

Job Description Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in

Full-time

USD 96,441.00 - 126,000.00 per year

Platform Information Security Officer (PISO), Life Sciences Platform

Remote

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Today

Bring more to life. At Danaher, our work saves lives. And each of us plays a part. Fueled by our culture of continuous improvement, we turn ideas into impact - innovating at the speed of life. Our 60,000+ associates work across the globe at more than 15 unique businesses within life sciences, diagnostics, and biotechnology. Are you ready to accelerate your potential and make a real difference? At Danaher, you can build an incredible career at a leading science and technology company, where we

Full-time

USD 225,000.00 - 275,000.00 per year

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

CSV Lead

Raritan, New Jersey

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Yesterday

Job Title- CSV Lead Job Location- Raritan, NJ (onsite) Job Description- Candidates need to have hands-on experience in validating and implementing infrastructure systems associated with Infrastructure related applications. Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environm

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Contract, Third Party

Depends on Experience

CSV Engineer

Raritan, New Jersey

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18d ago

Job Summary for CSV Engineer - Industry Experience: 3-7+ years of relevant experience in pharmaceutical, biotechnology, or medical device industries. - System Development Lifecycle: Proficient in Computer System Validation (CSV), especially in FDA and/or globally regulated environments. - Regulatory Standards: Strong understanding of GxP standards, risk-based validation, FDA guidances, and industry standards (e.g., GAMP). - Validation Documentation: Skilled in writing and executing validat

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Third Party, Contract

$50 - $56

GxP Deployment Lead – Kneat Gx

Hybrid in Raritan, New Jersey

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21d ago

GxP Deployment Lead Kneat Gx Location: Lawrenceville, NJ Onsite Experience: 10+ Years Employment Type: W2 / C2C (as applicable) Position Summary: We are seeking an experienced GxP Deployment Lead with hands-on expertise in Kneat Gx to lead the implementation, configuration, validation, and rollout of paperless validation and digital execution processes within a regulated life sciences environment.The ideal candidate will act as a bridge between Business, Quality, IT, and Validation teams, ensu

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Third Party, Contract

60 - 65

SAP Validation

Remote

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24d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Senior Automation Engineer

Remote or New Jersey

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14d ago

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

GAMP jobs in Summit, NJ, USA