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Computer System Validation Csv Remote Jobs in Reston, VA

TS/SCI Potential for Remote Work: ORA_HYBRID Description Join the Data Feed Integration (DFI) team ... data formats such as CSV, JSON, and XML for seamless and secure system compatibility.

This opportunity is full time in Bethesda, MD and/or remote work. As a Software Developer, you will ... CSV) * Understanding of ASN.1 a plus * Experience with version control systems like Git or SVN

Design, build, and operate large-scale Big Data systems, including persistence, partitioning ... Bachelor's degree in Geospatial Intelligence, Geography, Remote Sensing, Intelligence Studies ...

Must be a U.S. Citizen without dual citizenship - Bachelor's degree in Computer Science ... Remote Minimum Requirements TCS220, T4, Band 7 #TSTECH EEO Statement Maximus is an equal ...

Must be a U.S. Citizen without dual citizenship - Bachelor's degree in Computer Science ... Remote Minimum Requirements TCS220, T4, Band 7 #TSTECH EEO Statement Maximus is an equal ...

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Computer System Validation Csv Remote information

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How much do computer system validation csv remote jobs pay per hour?

As of Jul 13, 2026, the average hourly pay for computer system validation csv remote in Reston, VA is $56.51, according to ZipRecruiter salary data. Most workers in this role earn between $43.51 and $67.02 per hour, depending on experience, location, and employer.

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

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.

What are some common challenges faced by Computer System Validation (CSV) professionals working remotely, and how can they be addressed?

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) specialist in a remote role, and why are they important?

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.
What are popular job titles related to Computer System Validation Csv Remote jobs in Reston, VA? For Computer System Validation Csv Remote jobs in Reston, VA, the most frequently searched job titles are:
What cities near Reston, VA are hiring for Computer System Validation Csv Remote jobs? Cities near Reston, VA with the most Computer System Validation Csv Remote job openings:

Associate Director Senior Data Analyst (Clinical Sciences)

BioNTech SE

Gaithersburg, MD • On-site, Remote

$146K - $234K/yr

Other

Posted 13 days ago


Job description

Munich, Germany; Cambridge, US; Gaithersburg, US; Mainz, Germany; New Jersey, US   |   full time   |   Job ID: 11529 

About the role 

As Associate Director, Senior Data Analyst liaises with Clinical Science to understand business needs and identify solutions that align to overall strategies. Reviews, analyzes and evaluates business systems and user needs while acting as a technical SME in Clinical Data and Analytics. 

Your main responsibilities 

  • Represent DDI as data analyst and technical SME across Clinical functional areas
  • Document Data Transfer Agreements (DTAs) for external data exchange
  • Define and document data transformation logic and support implementation
  • Partner with Clinical stakeholders to evaluate business systems and needs
  • Support planning, prioritization, delivery, and operations of Clinical solutions
  • Develop and maintain process documentation (current and to-be)
  • Define system, functional, and business requirements
  • Provide technical SME support for clinical systems (EDC,  Elluminate, Databricks, analytics tools)
  • Support implementation and onboarding of new Clinical solutions
  • Manage vendor interactions and ensure service delivery and troubleshoot system and operational issues
  • Coordinate service operations and SLA compliance, support Computer System Validation (CSV) and GxP processes
  • Maintain validation documentation (URS, IQ/OQ/PQ, traceability, reports) and ensure alignment with quality systems and operational procedures 

What you have to offer

  • Bachelor's or higher degree in a relevant scientific or technical field
  • 10 -12+ years experience in Clinical Operations/Data Management
  • Strong understanding of Clinical business processes
  • Experience in process development, mapping, and gap analysis
  • Experience working with vendors and maintaining systems
  • Hands-on experience with SQL, reporting tools (e.g., Spotfire)
  • Knowledge of GxP, CSV, and SDLC and strong understanding of Clinical systems and data
  • Ability to translate business requirements into technical solutions and strong collaboration across business and IT teams
  • Ability to operate in global matrix organizations and strong communication and stakeholder engagement skills
  • Ability to manage change and prioritize based on business value 

Your benefits and remuneration:

If the position is filled in the US, the Expected Pay Range is $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. 
Compensation at other locations may vary significantly. 

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.