Gamp jobs in durham, nc

IT/OT Solutions Architect - GxP Manufacturing

Durham, North Carolina

•

Today

Position Overview Architect the digital backbone of FUJIFILM Biotechnologies manufacturing. As our Global Solution Architect (IS&O) - GxP Manufacturing, you'll translate complex business and technical needs into practical, scalable architectures that connect shop floor to top floor-MES, DCS/SCADA, historians, labs, networks, and the cloud. Your work will hardwire security and compliance into every design, accelerate delivery, and ensure our sites run safely, reliably, and inspection-ready. Join

Full-time

Lead Validation Engineer

Raleigh, North Carolina

•

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 and global scale allows us to help our clients develop and implement standardize

Full-time

Senior Controls Engineer - Operational Technology (Durham, NC)

Durham, North Carolina

•

Today

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop

Full-time

Commissioning, Qualification, and Validation (CQV) Engineer

Raleigh, North Carolina

•

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

Senior Engineer, Validation

Raleigh, North Carolina

•

Today

TITLE: Senior Engineer, Validation WHO WE ARE Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of p

Full-time

USD 88,000.00 - 105,000.00 per year

Equipment Validation Engineer 2

Durham, North Carolina

•

Today

Position Overview We are seeking an Equipment Validation Engineer II to support the qualification of manufacturing equipment and utilities in our GMP facility. You will develop and execute risk-based validation strategies, author and run IQ/OQ/PQ protocols, and partner with cross-functional teams to ensure compliant, reliable operations. Company Overview At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects

Full-time

Automation & Controls Engineer

Raleigh, North Carolina

•

Today

TITLE: Automation & Controls Engineer WHO WE ARE Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline o

Full-time

USD 98,000.00 - 115,500.00 per year

Data & AI Architect

Durham, North Carolina

•

Today

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but i

Full-time

USD 129,000.00 - 211,200.00 per year

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

•

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

•

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

Computer System Validation Engineer

Raleigh, North Carolina

•

14d ago

Job Description: We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications. The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle. The primary responsibility is to ensure that validation activities supporting Manufacturing

Full-time

SAP Validation

Remote

•

23d 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

Easy Apply

Contract

Depends on Experience

Senior Automation Engineer

Remote or New Jersey

•

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 Durham, NC, USA