computerized system validation Jobs

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Senior Engineer Computerized System Validation

Takeda pharmaceutical

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Social Circle, Georgia, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: The Computerized Systems Validation Engineering, is responsible for leading, managing, and performing engineering op
Posted 34 days ago | Updated 9 hours ago

Lead/Sr Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams
Posted 1 day ago | Updated 9 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 15 days ago | Updated 9 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 23 days ago | Updated 9 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.
Posted 60+ days ago | Updated 9 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 9 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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Kansas City, Missouri, USA

Full-time

Roles & Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports). Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manage
Posted 60+ days ago | Updated 9 hours ago

CQV Engineer-W2 ONLY

VetForce Solutions

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Holly Springs, North Carolina, USA

Contract

Title: CQV Engineer Location: Holly Springs, NC-onsite Duration: 6-12+ Months CQV Engineer Responsibilities (Typical): * Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC) * Managing and working collaboratively with clients quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis * Supporting clients change manag
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Posted 7 days ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 9 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Libertyville, Illinois, USA

Full-time

Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for the development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work a
Posted 60+ days ago | Updated 9 hours ago

Automation Controls Engineer-Infrastructure

Bytecubit Technologies

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Holly Springs, North Carolina, USA

Contract

Job Title: Mid Automation Engineer InfrastructureLocation: Holly Springs, NCDuration: 6 monthsPay rate: $60/hr -$70/hr (depending on experience) Job Description:Looking for an Infrastructure Automation DeltaV Support Engineer to support the DeltaV DCS Development, Validation, and Production systems supporting the Drug Substance Manufacturing (DSM) area of the facility.This role will support system validation, routine maintenance, troubleshooting, and user management during facility start-up and
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Posted 18 days ago | Updated 17 days ago

Sr. CSV Engineer

Katalyst Healthcares and Lifesciences

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Philadelphia, Pennsylvania, USA

Full-time

Roles & Responsibilities: Lab CSV consultant needed. Working on standard lab equipment systems, temp monitoring systems will be the first but will also include HPLC, and various other lab equipment. helping define a program and plan for validation. Work cross functionally with decision manager for writing SOPS and procedures, defining how to contribute to execution. There is a current team in place but they are scientists and not CSV experts so this person should really be 10+ years of e
Posted 20 days ago | Updated 9 hours ago

Automation Controls Engineer-CIP DeltaV

Bytecubit Technologies

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Holly Springs, North Carolina, USA

Contract

Job Title: Mid Automation Engineer CIP DeltaVLocation: Holly Springs, NCDuration: 6 monthsPay rate: $60/hr - $70/hr (depending on experience) Job Description:Looking for a Utilities & CIP Process Automation DeltaV Support Engineer to support the operational activities for Utilities & CIP equipment and systems contained within the Drug Substance Manufacturing (DSM) area of the facility.Equipment is controlled primarily by a DeltaV DCS.This role will support equipment start-up and to complete code
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Posted 18 days ago | Updated 17 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Franklin Township, New Jersey, USA

Full-time

Roles & Responsibilities: We are now looking for a resource on the validation side of things going on here. Depending on the resource, we're looking for someone with (LabVantage) LIMS and quality systems validation experience, and/or general more broad Pharma/Biotech CSV experience that could back-fill as staff augmentation. Engagement would be (at least) through the end of the year. Potential in-scope activities. i. CSV/Lab Systems Qualification document/deliverable authoring. ii. Test scr
Posted 7 days ago | Updated 9 hours ago

Computer Systems Quality Assurance (CSQA)

Hire IT People

•

Indianapolis, Indiana, USA

Full-time, Contract, Third Party

Job Title: Computer Systems Quality Assurance (CSQA) Location: Indianapolis, IN (Hybrid 3 days a week) Duration: 12+ Months Mandatory skills IT CSV IT QA / QA eCompliance Manager Experience with global patient safety, adverse event/product complaint reporting Job Description This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client's ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality ove
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Posted 4 days ago | Updated 4 days ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Roles & Responsibilities: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager. Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems. They will review and approve risk assessment link to CSV of systems. Collaborate with the other departments, within their respective areas of responsibility for Change Managemen
Posted 13 days ago | Updated 9 hours ago

Job Board Data Automation Engineer

Stellent IT LLC

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US

Full-time, Part-time, Third Party, Contract

Role : Job Board Data Automation Engineer Location : FULLY REMOTE Engagement: Freelance / project-based Required : Their relevant experience for this role (brief summary) Please provide relevant examples of WHY you know they can handle the scope of the project Links to any past projects, code samples, or portfolio Availability to start Location/time zone We're hiring a freelance engineer or data automation expert to help us build a custom scraping and export tool that pulls new job listings
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Posted 3 days ago | Updated 1 day ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Raritan, New Jersey, USA

Full-time

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service Now, Automation tools, JIRA. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. Application of FDA guidance's a
Posted 7 days ago | Updated 9 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Warren, New Jersey, USA

Full-time

Responsibilities and Requirements: Experienced with validation of stand-alone computer systems, such as benchtop analytical instruments and lab equipment controlled by software. Highly preferable if they have flow cytometry qualification experience. Experienced with qualification of air samplers also controlled by software. Experience with QC EM programs. Highly preferable if they have experience with Lasairs.
Posted 60+ days ago | Updated 9 hours ago

SUD Validation Engineer

Thermo Fisher Scientific

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Logan, Utah, 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 32 days ago | Updated 9 hours ago