Product Lead, Delivery & Operations
Armonk, NY · On-site +1
This role is not open to fully remote or hybrid work arrangements. Discover your role ... Knowledge of computer system validation, 21 CFR Part 11,GxP, CSV documentation (IQ/OQ/PQ ...
Armonk, NY · On-site +1
This role is not open to fully remote or hybrid work arrangements. Discover your role ... Knowledge of computer system validation, 21 CFR Part 11,GxP, CSV documentation (IQ/OQ/PQ ...
Armonk, NY · On-site +1
This role is not open to fully remote or hybrid work arrangements. Discover your role ... Knowledge of computer system validation, 21 CFR Part 11,GxP, CSV documentation (IQ/OQ/PQ ...
Warren, NJ · On-site +1
This role is not open to fully remote or hybrid work arrangements. Discover your role ... Knowledge of computer system validation, 21 CFR Part 11,GxP, CSV documentation (IQ/OQ/PQ ...
Warren, NJ · On-site +1
This role is not open to fully remote or hybrid work arrangements. Discover your role ... Knowledge of computer system validation, 21 CFR Part 11,GxP, CSV documentation (IQ/OQ/PQ ...
... trading system validation, certification, and integration support for electronic trading ... Benefits You Will Enjoy - Full-time position (mix of onsite and remote). - Competitive package ...
... trading system validation, certification, and integration support for electronic trading ... Benefits You Will Enjoy - Full-time position (mix of onsite and remote). - Competitive package ...
New York, NY · On-site +1
$122K - $143K/yr
This is primarily a remote contract role, with approximately 20% of working time hands-on at a U.S ... Infrequent travel to client sites for system setup and validation is expected as needed. Who You ...
New York, NY · On-site +1
$122K - $143K/yr
This is primarily a remote contract role, with approximately 20% of working time hands-on at a U.S ... Infrequent travel to client sites for system setup and validation is expected as needed. Who You ...
Familiarity with GxP validation and Computer System Validation (CSV). * ITIL or managed services experience. Benefits * 401k match * Comprehensive group health, dental, vision benefits * Life ...
Familiarity with GxP validation and Computer System Validation (CSV). * ITIL or managed services experience. Benefits * 401k match * Comprehensive group health, dental, vision benefits * Life ...
Piscataway, NJ · Remote
$36K - $120K/yr
IT Staffing Business Development Consultant About the Opportunity National Computer Systems is ... This is a flexible, remote, performance-based opportunity focused on client acquisition--not ...
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Piscataway, NJ · Remote
$36K - $120K/yr
IT Staffing Business Development Consultant About the Opportunity National Computer Systems is ... This is a flexible, remote, performance-based opportunity focused on client acquisition--not ...
Familiarity with GxP validation and Computer System Validation (CSV). * ITIL or managed services experience. Benefits * 401k match * Comprehensive group health, dental, vision benefits * Life ...
Familiarity with GxP validation and Computer System Validation (CSV). * ITIL or managed services experience. Benefits * 401k match * Comprehensive group health, dental, vision benefits * Life ...
Piscataway, NJ · Remote
$36K - $120K/yr
IT Staffing Business Development Consultant About the Opportunity National Computer Systems is ... This is a flexible, remote, performance-based opportunity focused on client acquisition--not ...
Quick apply
Piscataway, NJ · Remote
$36K - $120K/yr
IT Staffing Business Development Consultant About the Opportunity National Computer Systems is ... This is a flexible, remote, performance-based opportunity focused on client acquisition--not ...
Manhattan, NY · On-site +1
... Remote (132200) Qualified candidates can directly send your updated resume and contact info via ... computer system capabilities, workflow and scheduling limitations Job Responsibilities: • Gather ...
Manhattan, NY · On-site +1
... Remote (132200) Qualified candidates can directly send your updated resume and contact info via ... computer system capabilities, workflow and scheduling limitations Job Responsibilities: • Gather ...
New York, NY · Remote
$25 - $31/hr
Stay current on the software/systems commonly used Requirements * Strong technical troubleshooting ... Familiar with remote support tools * Reliable internet for remote work Benefits * Health and ...
New
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New York, NY · Remote
$25 - $31/hr
Stay current on the software/systems commonly used Requirements * Strong technical troubleshooting ... Familiar with remote support tools * Reliable internet for remote work Benefits * Health and ...
New
Bridgewater, NJ · On-site +1
$70K - $130K/yr
... the client's computer system validation lifecycle (URS, FRS, DS, IQ/OQ/PQ). • Act as key liaison with client stakeholders and cross-functional teams (Automation, IT, QA) to align on MES ...
Bridgewater, NJ · On-site +1
$70K - $130K/yr
... the client's computer system validation lifecycle (URS, FRS, DS, IQ/OQ/PQ). • Act as key liaison with client stakeholders and cross-functional teams (Automation, IT, QA) to align on MES ...
Manhattan, NY · On-site +1
... Computer Science, or a related discipline; professional certification (e.g., Microsoft, Azure, or ... remote). - Competitive package. - Career path in a technology company with many talented people.
Manhattan, NY · On-site +1
... Computer Science, or a related discipline; professional certification (e.g., Microsoft, Azure, or ... remote). - Competitive package. - Career path in a technology company with many talented people.
New York, NY · On-site +1
... AI systems by creating, reviewing, and refining mechanical CAD models and technical documentation ... Create, interpret, and validate detailed engineering drawings in accordance with ASME Y14.5 (or ...
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New York, NY · On-site +1
... AI systems by creating, reviewing, and refining mechanical CAD models and technical documentation ... Create, interpret, and validate detailed engineering drawings in accordance with ASME Y14.5 (or ...
Manhattan, NY · On-site +1
$75/hr
Assess and validate AI-generated content related to healthcare operations, medical coding, and ... systems, to complete and submit work products. Essential Skills * Professional experience ...
Manhattan, NY · On-site +1
$75/hr
Assess and validate AI-generated content related to healthcare operations, medical coding, and ... systems, to complete and submit work products. Essential Skills * Professional experience ...
Manhattan, NY · On-site +1
$75/hr
Assess and validate AI-generated content related to healthcare operations, medical coding, and ... systems, to complete and submit work products. Essential Skills * Professional experience ...
Manhattan, NY · On-site +1
$75/hr
Assess and validate AI-generated content related to healthcare operations, medical coding, and ... systems, to complete and submit work products. Essential Skills * Professional experience ...
Remote Duration: 6-Month Contract Experience: 5-6 Years Job Overview We are seeking a Regulatory ... Coordinate UAT, review test scripts, and support system validation activities. * Create and ...
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Remote Duration: 6-Month Contract Experience: 5-6 Years Job Overview We are seeking a Regulatory ... Coordinate UAT, review test scripts, and support system validation activities. * Create and ...
New York, NY · Remote
$95K - $115K/yr
Support and monitor data loads, mappings, and validation across multiple ERP systems for global ... Bachelor's degree in Computer Science, Information Systems, Finance, Accounting, Engineering, or ...
New York, NY · Remote
$95K - $115K/yr
Support and monitor data loads, mappings, and validation across multiple ERP systems for global ... Bachelor's degree in Computer Science, Information Systems, Finance, Accounting, Engineering, or ...
LOCATION: U.S. locations - remote/hybrid (8 days a month in the office). Candidates within ... across AI architecture, system validation, and clinical workflows, ensuring outputs remain ...
LOCATION: U.S. locations - remote/hybrid (8 days a month in the office). Candidates within ... across AI architecture, system validation, and clinical workflows, ensuring outputs remain ...
LOCATION: U.S. locations - remote/hybrid (8 days a month in the office). Candidates within ... across AI architecture, system validation, and clinical workflows, ensuring outputs remain ...
LOCATION: U.S. locations - remote/hybrid (8 days a month in the office). Candidates within ... across AI architecture, system validation, and clinical workflows, ensuring outputs remain ...
LOCATION: U.S. locations - remote/hybrid (8 days a month in the office). Candidates within ... across AI architecture, system validation, and clinical workflows, ensuring outputs remain ...
LOCATION: U.S. locations - remote/hybrid (8 days a month in the office). Candidates within ... across AI architecture, system validation, and clinical workflows, ensuring outputs remain ...
| Aspect | Computer System Validation Remote | Computer System Validation on-site |
|---|---|---|
| Work Environment | Performs validation tasks remotely, often from home or a different location from the client site. | Works directly at the client or company site, conducting validation activities in person. |
| Required Credentials | Typically requires certifications like GxP, 21 CFR Part 11, and validation experience, applicable in both settings. | Same certifications as remote roles, with additional familiarity with on-site equipment and facilities. |
| Industry Usage | Common in industries like pharmaceuticals and biotech where remote oversight is feasible. | Traditional in regulated industries requiring on-site validation activities. |
Both roles require similar certifications and industry knowledge, but the main difference lies in the work environment—remote versus on-site. Remote validation offers flexibility, while on-site validation involves direct interaction at the facility.
The most popular types of Computer System Validation jobs in New York are:
For Computer System Validation Remote jobs in New York, the most frequently searched job titles are:
The top searched job categories for Computer System Validation Remote jobs in New York are:
Cities in New York with the most Computer System Validation Remote job openings:

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 11 days ago
Lead GxP implementation of Data Lakehouse platforms and support exploratory non-GxP use cases.
Manage requirements analysis, design, configuration, and product delivery for data platforms and Human Sample Management.
Operate within an Agile delivery model to manage roadmaps, backlog prioritization, sprint planning, and stakeholder communication.
8.5
Based on 44 frontline employees who took The Breakroom Quiz
19th of 86 rated pharmaceutical
Build our future together:
The Regeneron Global Development IT (GD IT) BDM/CGM & ES Lead serves as theProductLeadfor the Data Lakehouse and Analytics platforms, partnering with Biostatistics Data Management (BDM), Clinical Genetics Medicine and Experimental Sciences (CGM/ES), compliance, and IT stakeholders to deliver compliant, scalable solutions. This role ownsrequirementsanalysis, roadmap alignment, backlog prioritization, and product delivery/execution across these platforms.Success in this role requires strong technical and domain expertise in data transfer and aggregation mechanisms from EDC,non-EDC (e.g., labs, biomarkers, and genetic data)and RWE sourcesas well as proficiency in R and Python for data management and statistical programming, and experience with AWS,Snowflakeand Databricks.Experience is Human Sample Data management fromClinicalTrial perspective is a huge plus.The role also demands strong Agile product delivery skills, cross-system integration experience, and adherence to globalGxPand regulatory standards.
When & where:
Based at our Warren, NJ or Armonk, NY locations.
4 days on-site per week required. This role is not open to fully remote or hybrid work arrangements.
Discover your role:
Responsibilities include
LeadGxPimplementation ofData Lakehouse (AWS,Snowflakeand Databricks), Positsolutions and support exploratorynon-GxPuse cases
Provide thought leadership and architectural inputs to shape a scalable future proof modern ecosystem
Manage Human Sample Management as a unified product across sites, labs, EDC systems, and internal LIMS, centralizing data to track specimen location, status, and chain of custody while automating reconciliations
Use AI and agents toenable digital transformation, from strategy to delivery, while remaining complaint and secure
Manage product roadmapsandtechnicalenablement
Lead end-to-end requirements analysis, design, and configuration
Manage scrum andkanbandashboardswithteamand ensuretimelystatus updatesto stakeholders
Gather requirements, manage enhancements, coordinate system changes and user testing, and support release and change management.
Operate within aproductbasedAgile delivery model, owning roadmap execution, backlog prioritization, sprint planning, UAT, release management, and continuous improvement using Jira and ServiceNow.
Drive stakeholder communication, change management, anddeliverytransparency, including status reporting, risk management, release communications, and cost/budget tracking.
Work with team to createmonthly/quarterly stakeholder communications, newsletters
Document standards, processes, and best practices; provide training to technical andnontechnicalteams.
Participate in governance forums (steering committees, working groups, change reviews) to ensure alignment andcrossfunctionalcollaboration
Develop strong business relationships to clarify needs,anticipaterequirements, and ensure solutions meet user expectations.
Establish end to end data governance procedures with stakeholders
This role requires:
BS/ Degree with10+ years relevantexperience.
MSor MBA with 6+ years preferred.Specifically inLife Sciences IT, Product Management, or Business/Systems Analysis with a strong focus onClinicalData Management and Analytics
Experience with data lakes/lakehouses(Snowflake, Databricks, AWS) supporting Clinical, RWE, and Safety data
Experience building data pipelines for transfer, cleaning, and aggregation from EDC (RAVE),eCOA, and non-EDC sources (lab, biomarker, genetic/omics data), including API and Regeneron Transfer Service (RTS) integrations
Experience with Human Sample Management
Hands-onproficiencyin SAS, R, and Python, including R Shiny development/deployment, APIs, SAS Viya/Posit, and AI automation for clinical R&D
Knowledge of CDISC standards (SDTM,ADaM) and Pinnacle 21
Understanding of Data Management and Safety functions - signal detection, data quality, query management, lab data reconciliation
Knowledge of CRO data transfer specs and data curation across studies/programs/therapeutic areas
Knowledge of computer system validation, 21 CFR Part 11,GxP, CSV documentation (IQ/OQ/PQ), traceability, change control
Understanding of blinded/unblinded datasets, interim analysis, and DB Lock sensitivities
Experience with ML and visual analytics (feature engineering, training, evaluation) via R, Python, SAS, Posit
Expertisewith Generative and Agentic AI (RAG, Agents, MCP, Claude, GPT)
Experience with AWS, DevOps, CI/CD workflows
Experience deploying analytical workloads/Shiny apps to cloud, including production troubleshooting
Experience with CRAN, Git/Bitbucket, version control best practices
Proficiencyin Agile Product Lead delivery - backlogs, user stories, sprint planning, UAT, roadmap alignment
Strong analytical and communication skills - translating technical/regulatory requirements for stakeholders
Knowledge of pharma R&D/clinical development processes, SDLC/SSDLC frameworks
Preferred Qualifications
Strong data management and clinical analytics background with data governance experience
Provenexperience in designing clinical data repositories, data lakes, data lake houses andoptimizingit for multiple teamssuch as Data Management, RWD, Statistical Programming
Experience providing technical leadershipon EDC and Non-EDC data integration into data lakes and data lake houses with other internal systemsacross business functions
Experience working in a highly matrixed organization and multi-disciplinary team
Experience managingstakeholderexpectations and ability to prioritize conflicts
Experiencewith JIRA for backlog and delivery management; exposure to ServiceNow-JIRA integrations
Certification or equivalentexperiencein product management
Good understanding ofAgentic AI andGenerative AI tools and capabilities
Background documenting best practices for configuration, data quality, release management, and governance
Veeva, Salesforce, or Product Management certifications
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$134,400.00 - $219,200.00Get the full story on Breakroom
Sourced by ZipRecruiter
Biotechnology research and development
5,001 - 10,000 Employees
Tarrytown, NY, US
1988