computerized system validation Jobs

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Information Technology Manager

ttg Talent Solutions

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Miami, Florida, USA

Full-time

Job DescriptionJob Title: Manager, IT Location: Coral Springs, FL (100% Onsite) Schedule: Full-time Salary Range: $135,000 $150,000/Year About the Role: Are you a strategic IT leader with a passion for managing technology in a regulated environment? This is your opportunity to lead the IT operations for a state-of-the-art R&D and GMP facility, ensuring efficient infrastructure management, regulatory compliance, and seamless user support. Based in Coral Springs, FL, this role is pivotal in mainta
Posted 4 days ago | Updated 18 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Jacksonville, Florida, USA

Full-time

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation departm
Posted 54 days ago | Updated 9 hours ago

Associate Technical Project Manager

S&P Global

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New York, New York, USA

Full-time

About the Role: Summary: The role will primarily focus on delivering implementations & integrations. Technical project managers may additionally be required to produce cross-training materials in the agreed, standardised formats; take on primary & secondary responsibilities when delivering implementations & integrations with other team members; and engage in product UAT cycles. Technical project managers at all levels are expected to collaborate with other members of professional services, and o
Posted 5 days ago

Data Integrity, Sr. Principal Associate - Lilly Medicine Foundry

Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 5 days ago | Updated 9 hours ago

Engineer - Quality FUME

Eli Lilly and Company

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Pleasant Prairie, Wisconsin, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 23 days ago | Updated 9 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Rocky Mount, North Carolina, USA

Full-time

Responsibilities: Lead CQV activities for new and modified filling lines, including isolator systems. Develop and execute IQ, OQ, and PQ protocols for filling equipment such as vial washers, dehydrogenation tunnels, filling machines, and capping systems. Perform risk assessments (e.g., FMEA) for filling line modifications and qualifications. Troubleshoot and resolve technical issues during qualification activities Clean Utility System. Manage CQV processes for clean utility systems, including pu
Posted 54 days ago | Updated 9 hours ago

Software Engineer II - Python

Chewy

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Boston, Massachusetts, USA

Full-time

At Chewy, it is our mission to become the most trusted and convenient online destination for pet parents and our partners - vets and service providers - alike. Our success is measured by the happiness of the people and pets we serve, not simply by the amount of pet supplies we deliver. That's why we continue to think of outside-the-Chewy-box ways to delight, surprise, and thank our loyal pet lovers! Our Opportunity: Chewy is seeking a Software Engineer to join the team in Plantation, FL or Bost
Posted 9 days ago | Updated 9 hours ago

Engineer - Automation/Process - Serialization

Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 22 days ago | Updated 9 hours ago

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

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Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee
Posted 54 days ago | Updated 9 hours ago

Data Integrity Lead

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Responsibilities: Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end-to-end business processes assessments. Prioritize gaps and risks and provide oversight to needed remediation activities. Serving as a Strategic Quality Lead (providing project management, leadership, and participation) for DTE computerized system life cycle (SLC) activities for Vertex GxP systems. Managing and Facilitating Data Mapping initiatives for programs level processes. Provi
Posted 54 days ago | Updated 9 hours ago

CSV Engineer

Sanofi

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Swiftwater, Pennsylvania, USA

Full-time

Job Title: CSV Engineer Location: Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/ Overview Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improv
Posted 14 hours ago

RPA Developer

IBM

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Chantilly, Virginia, USA

Full-time

Introduction A career in IBM Consulting is rooted by long-term relationships and close collaboration with clients across the globe. You'll work with visionaries across multiple industries to improve the hybrid cloud and AI journey for the most innovative and valuable companies in the world. Your ability to accelerate impact and make meaningful change for your clients is enabled by our strategic partner ecosystem and our robust technology platforms across the IBM portfolio; including Software and
Posted 51 days ago | Updated 9 hours ago

LIMS Master Data Specialist

Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Position Summary: Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Responsibilities: Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers. Provide electronic systems operational support and troubleshooting to end use
Posted 54 days ago | Updated 9 hours ago

Senior NetSuite Functional Consultant - hybrid onsite -2-3 days a week

Calance

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Long Beach, California, USA

Contract

Overview We are seeking an experienced Senior NetSuite Functional Consultant (SME) to lead process optimization and configuration efforts across our core NetSuite platform. This is a key role that bridges business needs with system capability working across departments such as Finance, Operations, Sales, and Supply Chain to maximize NetSuite s value. You will serve as a strategic partner to business and technology teams, enabling operational excellence through effective system configuration (non
Posted 18 hours ago | Updated 6 hours ago

Data Integrity QA Validation Engineer

Katalyst Healthcares and Lifesciences

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Rensselaer, New York, USA

Full-time

Responsibilities: Participate on teams of internal resources in delivery of CSV projects. Author functional requirements specifications that are complete, accurate, and testable. Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments. Author Validation Plans and Validation Reports. Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices. Experience in validation at least two of these computer system categories: automation contro
Posted 54 days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses ba
Posted 50 days ago | Updated 9 hours ago

MES Engineer

Eli Lilly and Company

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Concord, North Carolina, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 56 days ago | Updated 9 hours ago

Veeva PromoMats Business Analyst

NetHyve Technologies Inc

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No location provided

Contract

Join IBM's Veeva Practice team as a Strategist & Business Analyst for Veeva PromoMats, where you will be a key leader in shaping and proposing innovative solutions leveraging the power of Veeva and IBM's Consulting AI and Asset based capabilities. You will work closely with clients to understand their unique challenges and develop compelling, tailored solutions that drive digital transformation within healthcare & life sciences organizations. In this role, you will act as a trusted advisor, comb
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Posted 12 days ago | Updated 4 hours ago

Corporate Automation Utilities Engineer

Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 56 days ago | Updated 9 hours ago

Principal Engineer, Validation

Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f
Posted 52 days ago | Updated 9 hours ago