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 8 days ago | Updated 10 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 53 days ago | Updated 10 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 53 days ago | Updated 10 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 53 days ago | Updated 10 hours ago

Sr. Computer system Validation Engineer

Katalyst Healthcares and Lifesciences

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Saint Joseph, Missouri, USA

Full-time

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 Manager. Enga
Posted 53 days ago | Updated 10 hours 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 53 days ago | Updated 10 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 53 days ago | Updated 10 hours ago

Program Manager (Procurement Analytics) - EST Timezone only

Activesoft, Inc.

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Remote

Contract

Program Manager (Procurement Analytics) -Contract -Remote (EST time zone) Description: Program Manager (Procurement Analytics) and has Data analytics, Experience with stake holder management with Senior Leaders Required Skills:Program Management, Procurement Analytics, Data Analysis, Stakeholder Management, Microsoft Project, Budgeting & Forecasting, Risk Management, ITIL, Project Lifecycle Management, Vendor Management, Compliance (SOX, CSV), KPI Monitoring, PMO Governance, Power BI, SAP, SQL
Easy Apply
Posted 14 days ago | Updated 6 hours ago

Automation Controls Engineer (2ndShift)

Bytecubit Technologies

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Indianapolis, Indiana, USA

Contract

Job Title: Automation Controls Engineer (2nd Shift)Location: Indianapolis, INDuration: 6 monthsPay Rate: $45/hr-$55/hr (depending on experience) Job Description: This role will be responsible for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial production. Bachelor s degree in engineering, Computer Science, Automation, or related field with 7+ years of relevant engineering experience in the Pharmaceutical or Chemical indust
Easy Apply
Posted 13 days 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 53 days ago | Updated 10 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Roles & Responsibilities: Knowledge in Troubleshooting MATLAB compatibility issues and technical issues. Strong Experience in CSV. Strong creative, analytical and problem-solving skills. Experience in PLM Tool. Excellent Interpersonal / communication skills, Organizational / planning skills preferred. Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software. Ability to work efficiently, meet timelines, and communicate status (generate t
Posted 10 days ago | Updated 10 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 6 days ago | Updated 10 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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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 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. Ex
Posted 53 days ago | Updated 10 hours ago

CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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Austin, Texas, USA

Full-time

Roles and Responsibilities: Strong writing, grammar, and editing abilities to create clear and concise documentation. bility to adapt writing style to various audiences (e.g., end users, technical teams, or regulatory bodies). Document Design and Formattingo Proficiency with documentation tools. Knowledge of design principles to create well-structured documents (manuals, user guides, SOPs, etc.). Version Controlo Familiarity with tools like Git, SVN, or SharePoint to manage document revisions a
Posted 53 days ago | Updated 10 hours ago

Pharmaceutical Equipment Commissioning & Qualification Engineer

Zachary Piper Solutions, LLC

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Hopewell Township, New Jersey, USA

Full-time

Piper Companies is currently seeking a Pharmaceutical Equipment Commissioning & Qualification Engineer for an opportunity in Titusville, New Jersey or Raritan, New Jersey , to join a global pharmaceutical company. Responsibilities: Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products Develop, execute, and document equipment qualification protocols and test plans in accordance with cGMP regulations and industry standards C
Posted 23 days ago | Updated 20 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Robbinsville Township, New Jersey, USA

Full-time

Responsibilities: Company Product. 503B compounding facility. The project the contractor will be working on CSV remediation of Lab Equipment Systems. They cutoff of connection to the network and automated systems and are looking to garner them all into one standalone system. Requirements: Waters EMPOWER Data Management Systems, GAMP 3-4 ISP Guidelines different GAMP Category, 3-5 years Isolators, Documentation skills, clear and concise protocol writing attention to detail. Someone that can
Posted 53 days ago | Updated 10 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Raynham, Massachusetts, USA

Full-time

Responsibilities: Ask candidates if they have validated equipment and what type of equipment they have validated. Mechanical/manufacturing experience. Writing and executing validation protocols. CSV is nice to have, but if the candidate has done that exclusively it will not work. Requirements: A minimum of a Bachelor's degree in Engineering is required. Minimum of 1-3 years' experience in medical device manufacturing, Bio/pharma is also good Develop and implement processes to support the
Posted 53 days ago | Updated 10 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Raritan, New Jersey, USA

Full-time

Responsibilities: This resource will support the following related to our Service Industrialization (SI) project Review the Services SI excel spreadsheets for tools, applications and other technologies required to provide the service. There are about 21 spreadsheets Design and set up Mapping Structure for TS Services in SharePoint List Record the technologies from the excel spreadsheets in the Mapping Structure for each Service. Collect the CMDB information for each technology pulled from the sp
Posted 48 days ago | Updated 10 hours ago

SAS Programmer

Katalyst Healthcares and Lifesciences

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Marlborough, Massachusetts, USA

Full-time

Responsibilities: Subjects who discontinue within 7 days of dose reduction/interruption after experiencing a list of AEs. This listing might require data to be merged from AE, EX and DS domains. nalyse/tour data across multiple compounds and clinical studies from different phases to answer research questions. Requirements: 4+ years' experience as data analyst or SAS programmer in the pharmaceutical industry. Experience developing and validating specification file for SDTM and ADaM datasets.
Posted 53 days ago | Updated 10 hours ago

IT infrastructure CSV Consultant

Katalyst Healthcares and Lifesciences

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Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting
Posted 53 days ago | Updated 10 hours ago