computerized system validation Jobs

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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 54 days ago | Updated 3 hours ago

Senior Developer - UKG Workforce Management

Kforce Technology Staffing

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New York, New York, USA

Full-time

RESPONSIBILITIES: Kforce is working with a client in search of a Senior Developer - UKG Workforce Management, to join their team in NY! This position is full-time, direct hire and hybrid. Overview: In this role, the Senior Developer is responsible for developing, configuring, and maintaining UKG Pro Workforce Management (WFM) solutions, as well as integrating UKG Pro with other systems using Boomi. You will also collaborate closely with HR and IT teams to understand business requirements and tr
Posted 52 days ago | Updated 1 hour ago

Power BI Solution Architect

The Select Group

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Toronto, Ontario, Canada

Full-time

POWER BI SOLUTION ARCHITECT We are seeking an experienced Power BI Solution Architect to support a major healthcare initiative with one of our top consulting partners. This role requires a strong blend of functional and technical expertise, with an emphasis on delivering scalable and impactful Power BI solutions across the organization. LOCATION: GTA (Hybrid - occasional onsite in Markham) START DATE: ASAP (targeting late January/early February) DURATION: 3 months with strong potential for mu
Posted 60+ days ago | Updated moments ago

SAP Integration Lead

Judge Group, Inc.

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Boston, Massachusetts, USA

Full-time

Location: Boston, MA Salary: $75.00 USD Hourly - $80.00 USD Hourly Description: Job Title: SAP Integration Lead Location: Boston, MA (Hybrid) Duration: 6+ months Contract Need Locals Only Required Qualifications: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field8+ years of SAP integration experience, with 3+ years in a regulated pharmaceutical environmentExpertise in SAP CPI, PI/PO, IDoc/ALE, RFC, BAPI, and API-based integrationStrong understanding of SAP
Posted 7 days ago | Updated moments ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

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San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 54 days ago | Updated 3 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 54 days ago | Updated 3 hours ago

Manufacturing Engineer I

Russell, Tobin & Associates

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Eden Prairie, Minnesota, USA

Full-time, Contract

The Science Team at Russell Tobin & Associates supporting the Engineering team that has an opening for Manufacturing Engineer I in Eden Prairie, MN!Position Summary: We are seeking a Manufacturing Engineer to support production operations through process improvement and engineering support. This entry-level position is ideal for individuals with a technical background and a passion for driving operational efficiency in a manufacturing environment. Additional Details: Contract Length: 12 months w
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Posted 19 days ago | Updated moments ago

System Validation Engineer

SUPERMICRO COMPUTER INC

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San Jose, California, USA

Full-time

Job Req ID: 26943 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, pass
Posted 15 hours ago | Updated 3 hours ago

Senior Consultant - MDM Network (Remote)

Veeva Systems

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Remote or Raleigh, North Carolina, USA

Full-time

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation
Posted 11 days ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Rockford, Illinois, USA

Full-time

Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Maintain existing validated processes, coordinating internal and customer approvals as needed. Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals. Assist in the change control pro
Posted 54 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 29 days ago | Updated 3 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract
Posted 54 days ago | Updated 3 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in
Posted 54 days ago | Updated 3 hours ago

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati
Posted 54 days ago | Updated 3 hours ago

Internal Quality Auditor

Judge Group, Inc.

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Lewisville, Texas, USA

Full-time

Location: Lewisville, TX Description: Our client is currently seeking a Engineering Consultant Top 5 Qualifications Investigations, Root Cause Analysis, or Corrective Actions - Critical Experience in Computer System Validation - Critical Annual Product Review - Would be Nice Experience with Validation, Process, Cleaning, or Equipment Validation - Would be Nice Experience with Stability Programs - Would be Nice Preferred Certifications: Certified Quality Auditor Certified Quality Engineer
Posted 25 days ago | Updated moments 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 41 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 54 days ago | Updated 3 hours ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 17 days ago | Updated 3 hours ago

Cyber Security Architect

Leidos

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Doral, Florida, USA

Full-time

Leidos is seeking a Cyber Security Architect to join our SCITES 2 team in Doral, FL. The Leidos Digital Modernization Sector at Leidos currently is looking for a Cyber Security Architect to work onsite in Doral, Florida and have the opportunity to work in a high-profile IT and Cyber Services program supporting the United States Southern Command (USSOUTHCOM) Cyber Information Technology Enterprise Services (SCITES) 2 contract. Our customer maintains a highly demanding mission and requires our su
Posted 2 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 56 days ago | Updated 3 hours ago