computerized system validation Jobs

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CSV Engineer Role

Katalyst Healthcares and Lifesciences

•

Massachusetts, USA

Full-time

Job Description: The CSV Engineer will be responsible for validating and verifying computerized systems that control or interface with laboratory equipment, ensuring data integrity and compliance. This includes writing, reviewing, and executing validation documents in alignment with regulatory expectations. Responsibilities: Validate GxP computerized systems/analytical instruments such as liquid handlers, Cellaca MX, and robotic arms. Lead development and execution of Data Integrity documentat
Posted 37 days ago | Updated 10 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Nutley, New Jersey, USA

Full-time

Job Description: Looking for someone who has done Validation.Google Cloud Platform and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team. Responsibilities:
Posted 53 days ago | Updated 10 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 37 days ago | Updated 10 hours ago

Validation Lead

TechDigital Corporation

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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
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Posted 5 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Jersey City, New Jersey, USA

Full-time

Responsibilities: Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix. Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner). Ability to work with project team to facilitate intera
Posted 53 days ago | Updated 10 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active
Posted 23 days ago | Updated 20 days ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti
Posted 23 days ago | Updated 20 days ago

Automation Engineer (R1-R4)

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 10 hours ago

Regulatory Publishing Manager

Russell Tobin

•

San Diego, California, USA

Full-time

Job DescriptionThe Science team at Russell Tobin is supporting Leading Pharmaceutical Company to hire "Regulatory Publishing Manager" Key Responsibilities: Utilize IQVIA RIM Smart and Veeva Vault RIM to publish eCTD submissions and reports in accordance with FDA, EMA, and ICH guidelines.Perform QC of published eCTD submissions and work with team members to resolve technical or formatting issues.Format authored documents consistently; ensure submission-readiness of PDFs by editing bookmarks, hype
Posted 7 days ago | Updated 7 hours ago

Quality Control Manager

Zachary Piper Solutions, LLC

•

Wayne, Pennsylvania, USA

Full-time

Piper Companies is seeking a Quality Control Manager to join a reputable Biologics Quality Control Testing company located in Wayne, Pa. Responsibilities of the Quality Control Manager include: Lead projects, collaborate with clients and teams, and ensure expectations are met Oversee testing, manage deviations, and ensure adherence to global regulations Represent the team in audits, address issues, and implement corrective actions Manage assay development, validation, and ongoing compliance
Posted 38 days ago | Updated 20 days ago

Calibration Technician V

DivIHN Integration Inc

•

Durham, North Carolina, USA

Full-time

Job DescriptionTitle: Senior Calibration Technician Location: Research Triangle Park, NC Duration: 6 Months Job Description The Senior Calibration Technician, reporting to the Manager, Laboratory Operations, will be responsible for independently managing laboratory equipment calibrations, maintenance, and repairs in coordination with external vendors and laboratory staff at our RTP locations. Responsibilities Independently plans, schedules, and performs maintenance, calibration, and repairs on a
Posted 19 days ago | Updated 8 hours ago

Retail Capabilities Analyst

Kforce Technology Staffing

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St. Louis, Missouri, USA

Contract

RESPONSIBILITIES: Kforce has a client that is seeking a Retail Capabilities Analyst in Saint Louis, MO. Responsibilities: * Retail Capabilities Analyst will work with the Director to create and maintain BI tools that support Retail Sales teams * Meet with stakeholders to gather requirements and ensure delivered tools meet expectations * Combine data from various sources (SQL databases, Excel, csv, etc.) into a single data model * Demonstrate high standards for creating efficient, performant and
Posted 41 days ago | Updated 3 hours ago

Artificial Intelligence Machine Learning Engineer

SAIC

•

Naval Air Station Point Mugu, California, USA

Full-time

Job ID: 2506476 Location: POINT MUGU NAWC, CA, US Date Posted: 2025-06-06 Category: Engineering and Sciences Subcategory: Machine Learning Engineer Schedule: Full-time Shift: Day Job Travel: Yes, 10 % of the Time Minimum Clearance Required: Secret Clearance Level Must Be Able to Obtain: Top Secret Potential for Remote Work: No Description SAIC is looking for an Artificial Intelligence/Machine Learning (AI/ML) Engineer who will develop, research, and apply analytic models and deep lear
Posted 29 days ago | Updated 8 hours 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 10 hours ago

National Customer Service Specialist

MBA Consulting Services, Inc. (MBA CSi)

•

Topeka, Kansas, USA

Full-time

Job DescriptionMBA Consulting Services, Inc. is looking for a detail-oriented National Customer Service Specialist to support the U.S. Postal Service at their Topeka, KS facility. In this role, you ll play a key part in maintaining and improving the USPS s Security Lock policies, systems, and processes. You ll assist customers with ordering locks and keys, provide Tier 2 help desk support, and ensure accuracy in critical data files and records. If you re a collaborative problem-solver with advan
Posted 3 days ago | Updated 8 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 6 days ago | Updated 10 hours ago

7097 - Senior Cloud Developer ASP.NET Core / AWS

Staff Tech

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Sacramento, California, USA

Contract

Project Overview Staff Tech is seeking a Senior Cloud Developer to support a public-sector web portal modernization and data integration project. The selected consultant will contribute to the continued development of a secure data submission platform, used for collecting, validating, and managing large volumes of structured data. This project involves enhancing an existing codebase and building new modular components for future scalability. Key Responsibilities Enhance and extend a .NET Core 9
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Posted 6 days ago

Manager R&D Quality Risk Management- Princeton

Irvine Technology Corporation (ITC)

•

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 12 days ago | Updated 1 hour 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 44 days ago | Updated 10 hours 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 7 hours ago