CSV Lead (Computer System Validation Lead)
AceStack LLC
Role: CSV Lead (Computer System Validation Lead)
Location: Remote
Contract
Job Summary
The CSV Lead will be responsible for leading and managing Computer System Validation (CSV) activities to ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and industry best practices. The role involves overseeing validation strategies, documentation, risk assessments, and coordination with cross-functional teams.
Key Responsibilities
Location: Remote
Contract
Job Summary
The CSV Lead will be responsible for leading and managing Computer System Validation (CSV) activities to ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and industry best practices. The role involves overseeing validation strategies, documentation, risk assessments, and coordination with cross-functional teams.
Key Responsibilities
- Lead end-to-end Computer System Validation activities for GxP-regulated systems
- Develop and execute validation plans, protocols, and reports (VP, IQ, OQ, PQ)
- Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and data integrity guidelines
- Perform risk assessments and define validation strategies based on system impact
- Review and approve CSV deliverables and validation documentation
- Coordinate with QA, IT, Business, and Vendors during validation lifecycle
- Support audits, inspections, and regulatory submissions
- Manage change control, deviation, CAPA, and periodic reviews
- Mentor and guide CSV team members and provide technical leadership
- Ensure validation activities align with SDLC and Agile methodologies
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the CSV Lead (Computer System Validation Lead) in United States vacancy
- ...CSV Lead (Computer System Validation Lead) Location: Remote Contract The CSV Lead will be responsible for leading and managing Computer System Validation (CSV) activities to ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and industry...ComputerContract workRemote work
AceStack LLC
United States12 hours ago $85k - $120k
...ComplianceCity: BostonState: MA Veeva Systems is a mission-driven organization... ...of modern, cloud-based digital validation to the industry. As a Computer Systems Validation Lead / Program Manager, you’ll lead... ....We are seeking an experienced CSV professional to plan and support...ComputerPermanent employmentFull timeWork at officeLocal areaRemote workWork from home3 days per week- Job-ID32311628Reference26-00679Summary: Provide validation and testing services to ensure system integrity, data accuracy, and regulatory compliance for... ...records Compliance & Data Integrity Support CSV (Computer System Validation) activities and documentation Ensure...Computer
$95k - $145k
Position Summary Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory... ...team, you will be responsible for… Lead end-to-end validation activities... ...business, information systems, computer science, engineering, or...ComputerRemote workVisa sponsorship$50 - $55 per hour
...We are looking for Validation Lead - Hybrid for our client in Raritan, NJ . Job Title... ...Infrastructure Qualifications and Business Systems Validations. Experience leading or... ...and risk-based validation. Strong Computer System Validation (CSV) expertise, especially within...ComputerContract workOpenkyber
Juneau, AK2 days ago- ...Position: Validation Lead Location: Raritan, NJ *HYBRID * Duration: 1 Years Must Have Computer System Validation experience M&A related Data Migration and related infrastructure... ...Separations/Divestiture from J&J a huge plus. Strong CSV Expertise, especially within Acquisition/...Computer
Inherent Technologies
Raritan, NJ1 day ago - ...potential? The Position The purpose of Lead IT Validation & Compliance position is to provide subject matter expertise in Computer Systems Validation, process improvement, and IT... .... Work to identify efficiencies in the CSV program approach. Work to apply lessons...ComputerLocal areaNight shift
Novo Nordisk
West Lebanon, NHmore than 2 months ago - ...engineer focused on PCB bring up, functional validation, measurements of PCBs, and lab management... ...candidate will be defining and running system level tests on these PCBs and help to... ...position that will provide the opportunity to lead PCB bring up, functional validation, lab...Work at officeRemote work
- Job-ID29088572Reference24-02006CSV for SAP systems/projects To create| assign and track the project [module] work plans for... ...productivity.Additional requirement:"Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance with...Computer
$168k - $264.5k
NVIDIA's accelerated computing platforms move data at speeds that push... ...The Silicon Co-Design Group leads the boundary between what was... ...shapes how NVIDIA validates high-speed interfaces across... ...well hold protocol depth and system breadth simultaneously, never...ComputerFull time- ...growing, and we are looking for a Lead CSV Engineer who believes in the... ...based CSV strategies for new system implementations, software... ...configuration specifications, validation protocols, traceability... ...CandidateBS.in Engineering, Computer Science, Life Sciences or another...Computer
- ...Purple Drive Computer System Validation (CSV) Consultant Share Raritan, NJ Overview: Role Descriptions: • Demonstratable experience... ...21 CFR Part 11 implementation in Pharma industries. • Leading the Tech Writer team for preparing the test cases. • Co...Computer
Purple Drive
Raritan, NJ1 day ago - ...We are seeking an experienced Pharma IT Testing & Validation Delivery Lead to lead end-to-end testing and validation services for... ...testing frameworks. Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity...ComputerFull time
PB consulting
Boston, MAa month ago - ...focused on Technology Quality Manufacturing and MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of relevant experience. Key responsibilities include project...Remote work
$110k - $126k
...Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with... ...functional teams. Experience leading teams is essentialFlexibility... ...policies, and SOPsRepresent CSV in project teams and collaborate...ComputerWork at officeLocal areaFlexible hours3 days per week- ...from breakthrough hardware and battery systems to intuitive design, intelligent... ...The RoleThe Senior Safety Integration Validation Engineer Lead for SDV Architecture provides technical... ...Mechanical, Electrical, Mechatronics, Computer, Systems, or related discipline).5+ years...ComputerFull timeLocal areaWork from homeRelocation package
- ...Position Summary We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated... ...(Onsite) Administrative shift Responsibilities Lead Computer System Validation (CSV) activities for GMP computerized...ComputerShift work
Inteldot
Texasa month ago - ...Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery. Extensive experience... ...of 21 CFR Part 11, CSA guidelines, with 2+ years in computer systems validation and testing. Flexibility to work...ComputerWork at office
Exaways Corporation
Foster, CA3 days ago - ...Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role... ...our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve...ComputerFull timeWork at office
Praxisprecisionmedicines
Remote22 days ago $96k - $144k
...is filled.What will you do?As an EMS Validation Engineering Lead, you will play a lead role in ensuring... ...Electric’s (SE’s) Environmental Monitoring System (EMS) deployment meets all industry,... ...to computerized system validation (CSV).Customer & Project Coordination: Collaborate...Ongoing contractFull timeTemporary workWork at officeRemote workFlexible hours- Job-ID32217193Reference26-00544Job Summary: Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. The role focuses on driving validation strategy, closing compliance gaps, supporting...Computer
- ...need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. AWS, Azure, JIRA,... ...& Separations. Strong CSV Expertise, especially within Acquisition... ...relevant experience; has experience of leading/advising Junior and Senior resources...Remote work
Shrive Technologies LLC
Texas3 days ago $152k - $253k
...industry with groundbreaking developments in High-Performance Computing, Artificial Intelligence, and Visualization. Our work opens... ...autonomous cars.We are looking for an accomplished map data validation lead to perform the validation of HD/SD map data, a vital component...ComputerFull time$129k - $161k
...Title: Test & Validation Lead Belong. Connect. Grow. with KBR! KBR is seeking an experienced... ...to support the MSEIT contract at Space Systems Command (SSC). This role is responsible... ...~ Bachelor's degree in engineering, computer science, math, physics, or related...ComputerFull timeContract workWork at officeLocal areaWork from homeFlexible hoursShift workKBR
El Segundo, CA18 days ago- ...from Beautiful Santa Cruz Imagine leading the verification and validation program for life-saving robotics... ...to own the strategy that proves our systems meet the rigorous standards that patient... ...Requirements: ~ BS in Computer Science, Software Engineering, Biomedical...ComputerWork at office3 days per week
- ...that accelerate next-generation computing experiences—from AI and data... ...to PCs, gaming and embedded systems. Grounded in a culture of... ...as part of the post-silicon validation group; facilitating all aspects... ...POR quality. The system debug lead will also help in driving improvements...Computer
- ...Description Job Description Validation & Engineering Group,... ...Pinnaql company is a leading services supplier who... ..., Compliance, Computer, Engineering, Project Management... ...position: ~ Computer System Validation Specialist... ...System Validation (CSV) Specialist/Engineer...Computer
- Public Consulting Group LLC (PCG) seeks experienced User Acceptance and System Testers to support software implementations across public sector clients. You will design, execute, and document testing to verify alignment with business, technical, data, and process requirements...
$117k - $201.25k
...Navigation Systems Verification & Validation (V&V) Engineering Manager At Johnson & Johnson, we believe... ...Navigation Systems V&V Engineering Manager leads a team of Verification & Validation... ...Skills: Preferred Skills: Computer Programming, Consulting, Critical...ComputerLocal areaImmediate startJ&J Family of Companies
Raynham, MA1 day ago- Job-ID32939620Reference26-01619 Summary: The Validation Lead is responsible for leading end-to-end validation activities within a regulated... ...equipment, facility/utilities, cleaning, and/or computerized system validation depending on the program. Responsibilities: Lead...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CSV Lead (Computer System Validation Lead). Be the first to apply!
Related searches
- validation manager United States
- entry level computer information technology United States
- computer maintenance United States
- computer tech United States
- computer programming internship United States
- computer support United States
- computer builder United States
- computer aid United States
- computer systems administrator United States
- computer programmer United States