GxP jobs in Newark, DE

Remote

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4d ago

Title: IT Project Manager with GxP Location: Boston MA (1x Month) Duration: 6 Months Visa: No H1b Need an IT/Infrastructure PM with recent Pharma and GXP experience. Must have experience working with MSPs or Vendors Description: The Project Manager will be responsible for the end-to-end project lifecycle of multiple simultaneous IT projects in a GxP regulated environment. The PM will engage in new and in-flight projects to ensure project resources are aligned to deliver on schedule and within

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Full-time

70 - 75

Project Manager - Pinnacle 21, GXP | 100% Remote | Contract

Remote

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5d ago

Our direct client a large global R&D driven pharmaceuticals company is seeking to hire a Project Manager for their Pinnacle 21 upgrade project.This is 6 months plus contract. Job Title: Project Manager - Pinnacle 21 upgrade project Duration: 6 months (may extend) Location: 100% Remote (work per eastern time)Pinnacle 21 solution is critical for SQS.For this role client is looking for System upgrade experience as a Project Manager and from IT perspective.The tool provides the quality of submissio

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Contract

Depends on Experience

Computer System validation Engineer

Wilmington, Delaware

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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

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

Lead Solution Architect

Remote

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10d ago

Lead Solution Architect Remote (Eastern Time Zone) Location: Remote (must be available to work in the Eastern Time Zone)Travel: Up to 25% travel to client site in North Carolina as needed. About the RoleWe are seeking a highly skilled Enterprise Architect for a Greenfield manufacturing facility project, who will be the site team liaison between IT and business cross functional teams to ensure the quality delivery of 40+ digital capabilities for the new site from an architecture perspective.Key R

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Contract

Depends on Experience

Senior Automation Engineer

Malvern, Pennsylvania

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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 79,000.00 - 120,700.00 per year

Agilent OpenLAB CDS Analyst

Remote

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Today

Job title: Agilent OpenLAB CDS Analyst Work Location: Rahway, NJ (Remote with Travel) Duration: Long Term Contract Job Description The Senior Technical Analyst will be responsible for supporting configuration, build, validation, & release activities for the successful release of a global enterprise Agilent OpenLAB CDS 2.x platform (OL:CDS), supporting and managing lab deployment resources in Agilent Instrument Controllers (AIC) builds, deployments, & troubleshooting efforts, and oversight of po

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Contract

Depends on Experience

Product Manager - Veeva Vault

Remote

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10d ago

Role: Veeva Vault Product Manager Location: Remote Job Type: FTE/ Full- Time Experience Range: 10- max 22 years Primary Skills: 1. Experience with system integrations (e.g., CTMS eTMF/EDC/Data Lakes & repositories) 2. Experience working with Siebel (CTMS) 3. Experience working with Veeva Managed Services or vendor escalations 4. Familiarity with Agile or DevOps methodologies 5. Knowledge of clinical metrics and reporting tools Required Bachelors degree in Life Sciences, Information Systems, o

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Full-time

Depends on Experience

Veeva Vault Product Manager

Remote

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6d ago

Veeva Vault Product Manager Clinical SME | Remote | FTE Location: Remote Employment: FTE Experience: 1022 Years We are hiring an experienced Veeva Vault Product Manager / Clinical Systems SME with strong expertise in Veeva Vault Clinical (CTMS & eTMF) and clinical trial operations. Key Requirements: 812+ years of experience delivering/leading regulated enterprise or clinical systems initiatives Deep hands-on experience with Veeva Vault Clinical CTMS & eTMF Strong understanding of clinical tria

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Full-time

Depends on Experience

Project Manager (Lifesciences / Biotech- Medical affairs)

Remote

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Today

Project Manager (Lifesciences / Biotech- Medical affairs) Foster City, CA (OR) Raleigh, NC (OR) Remote Full-Time / Direct-Hire Salary Market- Based on Experience Hiring an experienced Project Managers to lead and coordinate technology and business initiatives supporting Medical Affairs functions. The role will serve as the primary liaison between stakeholders, Medical Affairs, business teams, IT teams, vendors, and delivery partners to ensure successful planning and execution of projects and o

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Full-time

$135000 - $145000

Senior Director, Light-Track Delivery & AI Automation

Remote

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Today

About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate

Full-time

Senior Technical Business Analyst

Remote

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6d ago

DescriptionJob Title: Senior Healthcare Business Analyst Type: Part Time Experience Level: Senior Seeking a highly skilled and experienced Senior Business Analyst responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes

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Part-time

Depends on Experience

Senior Engineering/ IT Program Manager

Remote or Ponce, Ponce

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Today

Job Title: Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 Months Location: 100% Remote (Travel to Ponce, Puerto Rico as needed) Role Overview Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership Manage enterprise engineering programs Build roadmaps, milestones, and resource plans Deliver withi

Full-time

Business Application & Systems Administrator

Remote or Boston, Massachusetts

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Today

Job Description The Business Applications & Systems Administrator is responsible for managing, implementing, and optimizing business applications. The role will develop & coordinate testing with impacted departments, including specifically coordinating with IT and Quality for validation & compliance. Manages business application projects, ensuring effective communication across teams/functions as well as informing management of progress and key issues. Key Responsibilities Application Managem

Full-time

USD 116,800.00 - 219,000.00 per year

AI Practice Lead - Life Sciences & Healthcare

Remote or New York, New York

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Today

EPAM AI consulting practice focuses on unlocking business value for organizations through end-to-end AI/ML solutions and platforms. From advanced analytics, marketing intelligence, and NLP to Responsible AI and MLOps, EPAM has delivered hundreds of solutions to production. We are looking for an AI leader to spearhead the initiatives across our Life Sciences and Healthcare Portfolio. This is a role where you will oversee the entire lifecycle of AI solutions, from ideation through delivery and gro

Full-time

AI Practice Lead - Life Sciences & Healthcare

Remote

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Today

Full-time

Staff Engineer - ML Operations - USA Remote

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're

Full-time

USD 180,000.00 - 220,000.00 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

Staff Forward Deployed AI Solutions Engineer

Remote

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Today

About the role The Staff Forward Deployed Solutions Engineer will work directly within a business domain (e.g., Commercial, Clinical Operations, Lab Operations, Sales & Marketing, Customer Experience etc.). In your role, you'll find opportunities for enhancing efficiency and productivity by looking for workflows which can be executed 10-100x faster or more often than a human team could using AI agents, integrations and other patterns. You will build, deploy, and run them in production. You rep

Full-time

USD 152,100.00 - 190,100.00 per year

Forward Deployed AI Solutions Engineer

Remote

•

Today

About the role The Forward Deployed Solutions Engineer will work directly within a business domain (e.g., Commercial, Clinical Operations, Lab Operations, Sales & Marketing, Customer Experience etc.). In your role, you'll find opportunities for enhancing efficiency and productivity by looking for workflows which can be executed 10-100x faster or more often than a human team could using AI agents, integrations and other patterns. You will build, deploy, and run them in production. You report in

Full-time

USD 105,700.00 - 132,100.00 per year

GxP jobs in Newark, DE, USA