computer system validation csv manager Jobs

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Sr. Software Quality Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 3 hours ago

Global IT Compliance Sr Specialist

Thermo Fisher Scientific

•

Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 8 days ago | Updated 4 hours ago

Validation Lead

TechDigital Corporation

•

King of Prussia, Pennsylvania, USA

Third Party, Contract

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
Easy Apply
Posted 19 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, 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 equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 10 days ago | Updated 3 hours ago

Engineer - Syncade or PharmaSuite MES System

Eli Lilly and Company

•

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 2 days ago | Updated 3 hours ago

Automation Engineer - Global Serialization Program

Eli Lilly and Company

•

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 8 days ago | Updated 3 hours ago

Engineer - Syncade or PharmaSuite MES System

Lilly

•

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 4 days ago | Updated 3 hours ago

Engineer - Syncade or PharmaSuite MES System

Lilly

•

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 5 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 4 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 4 hours ago

Jr. Data Engineer (Langchain, Spark) - Remote

ConsultNet, LLC

•

Remote or South Jordan, Utah, USA

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
Easy Apply
Posted 31 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 60+ days ago | Updated 4 hours ago

Sr. Principal Engineer - QA

Eli Lilly and Company

•

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 10 days ago | Updated 3 hours ago

Engineer - MES System

Eli Lilly and Company

•

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 32 days ago | Updated 3 hours ago

Techno Functional SAP WMS/TMS Consultant

TEKsystems c/o Allegis Group

•

Waukegan, Illinois, USA

Full-time

Top Skills Details 9+ years of SAP WM (Warehouse Management)9+ years of SAP TM (Transportation Management) Description We are seeking a highly skilled Techno-Functional Contractor with deep expertise in SAP Warehouse Management - preferably Manhattan Active-and Transportation Management to support major transformational initiatives in the life sciences sector. The ideal candidate will bridge the gap between business needs and technical solutions, ensuring seamless integration and optimization of
Posted 12 days ago | Updated moments ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 43 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 4 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 department.
Posted 60+ days ago | Updated 4 hours ago

Engineer III, Validation

Thermo Fisher Scientific

•

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 55 days ago | Updated 4 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

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 59 days ago | Updated 3 hours ago