computer system validation csv engineer Jobs

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Manager R&D Quality Risk Management- Princeton

Irvine Technology Corporation (ITC)

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Princeton, New Jersey, USA

Contract

Manager, R&D Quality Risk Management - Hybrid- Princeton, NJ Join our client as a Manager, R&D Quality Risk Management, where you ll play a pivotal role in overseeing computer system validation (CSV) activities across GxP systems. This position offers the opportunity to work in a highly regulated environment, collaborate cross-functionally, and ensure systems comply with evolving global standards in data integrity and compliance. If you thrive in a quality-driven, dynamic R&D environment, this
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Posted 8 days ago | Updated moments ago

IT infrastructure CSV Consultant

Katalyst Healthcares and Lifesciences

•

Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting
Posted 49 days ago | Updated 3 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 2 days ago | Updated 3 hours ago

Sr. Software Quality Engineer (CSV)

Katalyst Healthcares and Lifesciences

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Texas, 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 49 days ago | Updated 3 hours ago

Validation Lead

TechDigital Corporation

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King of Prussia, Pennsylvania, USA

Contract, Third Party

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf
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Posted 20 hours ago

Program Manager (Procurement Analytics) - EST Timezone only

Activesoft, Inc.

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Remote

Contract

Program Manager (Procurement Analytics) -Contract -Remote (EST time zone) Description: Program Manager (Procurement Analytics) and has Data analytics, Experience with stake holder management with Senior Leaders Required Skills:Program Management, Procurement Analytics, Data Analysis, Stakeholder Management, Microsoft Project, Budgeting & Forecasting, Risk Management, ITIL, Project Lifecycle Management, Vendor Management, Compliance (SOX, CSV), KPI Monitoring, PMO Governance, Power BI, SAP, SQL
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Posted 9 days ago | Updated 20 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 basic
Posted 47 days ago | Updated 3 hours ago

IDAP MES System Engineer Tech@Lilly

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 29 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Massachusetts, USA

Full-time

Job Overview: Our client seeking an experienced CSV / IT GxP Consultant. This role will focus on ensuring the alignment of internal policies with federal and state regulations, improving our Computer System Validation (CSV) processes, and enhancing third-party vendor compliance. The position will also involve developing and implementing SOPs, as well as managing data privacy and retention policies. The ideal candidate will have experience in GxP regulations and a strong understanding of IT proce
Posted 49 days ago | Updated 3 hours ago

Experienced Automation Engineer (CSV)

Johnson & Johnson

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Wilson, North Carolina, USA

Full-time

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
Posted 51 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Portsmouth, New Hampshire, USA

Full-time

Responsibilities: Hands on experience in Implementation & Validation of various computerized systems like MES (Syncade) & PLC (COTS). Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements. Experience at working independently as well as in a team-oriented, collaborative environment is essential. Author and Execute CSV life cycle documentation. Requirements: CSV experience of 4+ years.
Posted 44 days ago | Updated 3 hours ago

Data Systems Engineer

Merck KgaA

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Jaffrey, New Hampshire, USA

Full-time

Work Location: Jaffrey, New Hampshire Shift: Department: LS-SC-PEJBGD Data Systems Recruiter: Renay Middleton Hiring Manager: Sija Jacob This information is for internals only. Please do not share outside of the organization. Your Role: In this role you will support the integration of various manufacturing equipment with networks, computers, printers, scanners, MES, Data Historian, bespoke applications and SPC systems. They will also manage related project work while collaborating with IT in
Posted 18 days ago | Updated 3 hours ago

Engineer - MES System

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 14 days ago | Updated 3 hours ago

Central Automation Engineer- CSV / Data Integrity

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 51 days ago | Updated 3 hours ago

Jr. Data Engineer (Healthcare, Spark, Scala) - Remote

ConsultNet, LLC

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Remote

Full-time

Title: Jr. Data Engineer, Healthcare Location : 100% Remote Target Start Date : ASAP Type: contract or contract to hire Pay Rate: DOE Are you driven by working to improve our healthcare system through advanced technology? We need your expertise and integrity! This role is 100% remote and we are looking for candidates who have healthcare domain expertise. Responsibilities Design, maintain, and execute intermediate-to-advanced Apache Spark jobs (using RDDs, DataFrames, Datasets, and Structur
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Posted 12 days ago | Updated 3 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 49 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 49 days ago | Updated 3 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 36 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Warren, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev
Posted 25 days ago | Updated 3 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S
Posted 40 days ago | Updated 3 hours ago