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Computer System Validation Csv Remote Jobs in New York

Esprow

System Administrator (Remote)

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.

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Computer System Validation Csv Remote information

What is the difference between Computer System Validation Csv Remote vs Computer Validation Specialist?

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

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The most popular types of Computer System Validation Csv jobs in New York are:

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Cities in New York with the most Computer System Validation Csv Remote job openings:

Computer System Validation Csv Remote jobs near you

Product Lead, Delivery & Operations

Regeneron Pharmaceuticals

Armonk, NY • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 11 days ago

Key responsibilities

  • 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.

Regeneron rating

8.5

Company rating: 8.5 out of 10

Based on 44 frontline employees who took The Breakroom Quiz

19th of 86 rated pharmaceutical

Job description

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 - $219,200.00

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