computerized system validation jobs

New Jersey

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines. Experience with ERP, LIMS, MES, or other GxP systems. Extensive Experience in HPALM with Manual testing. Deep knowledge in Defect Management Life cycle. Proficient in writing validation protocols, reports, and SOPs

Full-time

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Computer system validation Engineer (CSV)

Bridgewater, New Jersey

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Today

Roles & Responsibilities: Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management. Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle). Experience in SAP/ERP Validation and test management. Experience leading IT risk, IT quality and IT compliance transformational programs. Experience in e

Full-time

Quadient Developer

Hybrid in Hartford, Connecticut

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10d ago

Title: Quadient Developer Location: Hartford, CT (Hybrid) Duration: 6+ months Job Description: Must-Have Skills:Experience with Quadient Inspire (Designer, Interactive, Automation, and Scaler)Expertise in document composition, template design, and variable data handlingExperience with data integration (XML, JSON, CSV, APIs) and output generation (PDF, print, email, SMS)Good understanding of communication workflows and version controlAbility to work with business users and technical teams to gat

Easy Apply

Contract

$45 - $45

Computer System Validation Engineer

Bothell, Washington

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Today

Job Description: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supp

Full-time

Validation Engineer

Buffalo Grove, Illinois

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Today

Job Description: Strong knowledge of ERP systems. (implementations/validation). Expert writing test scripts, test functionality, data flow, documentation. CSV-Computer systems validation. Requirement management exp. (supporting planning for requirements, integrating requirements and the organization for working with them). Has worked in the manufacturing/med device space.

Full-time

MES Analyst

San Jose, California

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21d ago

MES Analyst Bay Area, CA - Locals only6+ Months Top Skills: Siemens Opcenter MES and CAMSTAR Manufacturing Consulting Medical DevicesJob Description: A dynamic professional with proven expertise in Siemens Opcenter Medical Devices in Manufacturing Execution domain. Design and architect multi-site MES Opcenter implementation based on discussion with business teams and their processesShould have Experience on LOFTWARE PRISYM 360 Understand the paper Batch record and business process flow in collab

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Contract, Third Party

$60 - $70

IT Manager

No location provided

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2d ago

Position:IT Manager Location:Lake Forest, IL (Onsite with some flexibility) Duration:Contract-to-Hire Job Summary: We are seeking a hands-on IT Manager with a strong background in life sciences to oversee IT operations, infrastructure, vendor management, and regulatory compliance. This role requires technical expertise along with leadership to drive secure, validated systems in a regulated environment supporting R&D, Quality, Clinical, and Commercial teams. Must-Have: Strong technical background

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Contract

80 - 90

Validation Engineer

Raritan, New Jersey

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Today

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation skills. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities: Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ,

Full-time

Software Validation Engineer

Plymouth, Minnesota

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good exp

Full-time

Validation Engineer

Hillsboro, Oregon

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Today

Responsibilities: Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance. Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables). Update existing validation deliverables and procedures in collaboration with the system owners. pply ALCOA+ principles to validation deliverables and quality management system records. Support in deviation investigations to identify root causes and define corre

Full-time

Computer Systems Quality Assurance (CSQA) with Validation (CSV)

Indianapolis, Indiana

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16d ago

Job Title: Computer Systems Quality Assurance (CSQA) with Validation (CSV) Location: Indianapolis, IN (Onsite) Duration: 12+ Months Job Description: Please not that 1 F2F round is mandatory. Mandatory skills: IT CSV Validation of IT systems IT QA / QA eCompliance Manager Experience with Veeva Quality Docs, ServiceNow, JIRA and HP ALM Pharma industry experience is mandatory Medical device experience is good to have This Computer Systems Quality Assurance role will be responsible for supporting

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Full-time, Contract, Third Party

$DOE

Workday Data Conversion Analyst near-shore

Remote

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Today

Title: Workday Data Conversion Analyst near-shore Location: Remote (Mexico) Target Start Date: December 1, 2025 Type: Project 9-12m Role Overview The Workday Data Conversion Analyst works under the Data Conversion Lead to prepare, transform, and load legacy HR data into Workday. They populate EIB templates, clean data, and validate accuracy after loads. This role ensures multiple load cycles are completed accurately and clean data is available for testing and cutover. Key Responsibilities Prepa

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Full-time

Verification Support Engineer

Louisville, Kentucky

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Today

Roles & Responsibilities: Pharmacy Verification Support engineer for a minimum of 4 years. Working knowledge of software or system validation in regulated industry like Medical Device or Pharma. Strong knowledge and experience of computerized system development life cycle (SDLC) approaches and validations strategies is required. Experience with COTS/Custom made Analytical Instrument and experience working in QC Laboratories, R&D, manufacturing/operations is required. Software Quality Engineer (S

Full-time

CSV Engineer

Indianapolis, Indiana

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Today

Responsibilities: Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning. Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans. Support execution of validation activities in alignment with the approved Validation Plan and CSV documentation standards. ssist Project CSV Leads in generating/editing CSV documents and electronic testing templates. Recom

Full-time

Staff Validation Engineer (West Hills, CA)

Los Angeles, California

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardotoxic materials Job Description When you're part of Thermo Fisher Scientific, you'll do exciting work and be part of a team that values performance, quality, and innovation. As part of a su

Full-time

USD 103,100.00 - 154,700.00 per year

Validation Engineer II

La Verne, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 99,705.00 - 129,030.00 per year

PCS 7 Validation Engineer

Woodinville, Washington

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Today

Job Description: We are seeking a highly skilled and detail-oriented PCS 7 Validation Engineer to join our Automation/Validation team. This role will focus on developing and maintaining validation documentation for Siemens PCS 7 control systems within a regulated GxP environment. Your expertise will ensure compliance with FDA, EU, and GAMP 5 standards while supporting system readiness for production. Although primarily a documentation-focused position, you may also provide on-site execution sup

Full-time

Engineer III, Automation Engineering

Cincinnati, Ohio

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Location/Division Specific Information Thermo Fisher Scientific Inc. is currently seeking a Engineer , Automation Engineering for our Cincinnati facility. By joining our team, you will have the opportunity to make a tangible difference and receive the appropriate support needed to accomplish your professional aspirations. How will you make an

Full-time

IT CSV Engineer

Boston, Massachusetts

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Today

Responsibilities: Works with the project team to author qualification deliverables such as Infrastructure/Network specifications, Qualification Protocols, Test Cases, Risk Assessments, and Summary Reports. Develop system development life cycle documents related to site infrastructure. This includes system specification documents, qualification plans and test protocols, and procedures. Coordinate qualification activities, propose and implement qualification strategies. Support the operational tea

Full-time

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computerized system validation jobs