CSV Engineer Jobs in New Jersey

Refine Results
1 - 12 of 12 Jobs

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 4 days ago | Updated 8 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor 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 degree
Posted 13 days ago | Updated 8 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Role & Responsibilities: 3-7 years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area. Has working experience in any one or two of the following domains Tool validation like ServiceNow, 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. pplication of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 2
Posted 60+ days ago | Updated 8 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 60+ days ago | Updated 8 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 60+ days ago | Updated 8 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 8 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 8 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 8 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

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 8 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses ba
Posted 60+ days ago | Updated 8 hours ago

CSV Lead

Prudent Technologies and Consulting

•

Raritan, New Jersey, USA

Third Party, Contract

Role - CSV Lead Location - Raritan, NJ(Hybrid) Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool val
Easy Apply
Posted 5 days ago

IT infrastructure CSV Consultant

Katalyst Healthcares and Lifesciences

•

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