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Computer System Validation Csv Remote Jobs (NOW HIRING)

Everest Technologies, Inc.

Sage ERP Technical SME

Direct technical exposure to regulatory frameworks, automated audit trails, electronic signatures, and computerized system validation (CSV). * Programming & DB: Mastery of Safe-X3 development ...

Syner-G

Validation Engineer

Boston, MA · On-site +1

... systems validation. * Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, and ... While performing the duties of this job, the employee is regularly required to use a computer ...

Wise Skulls

PRMS Architect

United States (Remote) Duration: 6 months (possibility of an extension) Implementation Partner ... Knowledge of GxP, validation (CSV), data integrity * Integration experience across enterprise ...

Clinical Ink

Documentation Manager

Experience with computerized system validation (CSV) and software testing documentation * Proficiency with document management systems (e.g., VeevaVault, MasterControl, or similar) * Excellent ...

Zifo

Veeva QMS Consultant

Bloomington, IN · On-site +1

**This role is open to remote candidates who have availability to travel to the client in Bloomington ... Computer Systems Validation is required for this role * Strong knowledge of GxP Requirements, GLP ...

Zifo

Veeva QMS Consultant

Bloomington, IN · On-site +1

**This role is open to remote candidates who have availability to travel to the client in Bloomington ... Computer Systems Validation is required for this role * Strong knowledge of GxP Requirements, GLP ...

Zifo

Veeva QMS Consultant

Bloomington, IN · Remote

**This role is open to remote candidates who have availability to travel to the client in Bloomington ... Computer Systems Validation is required for this role * Strong knowledge of GxP Requirements, GLP ...

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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 Jun 19, 2026, the average hourly pay for computer system validation csv remote in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 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.
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Computer System Validation Csv Remote jobs near you
Infographic showing various Computer System Validation Csv Remote job openings in the United States as of June 2026, with employment types broken down into 100% Contract. Highlights an 100% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Senior Clinical Trials IT Business Analyst

Senior Clinical Trials IT Business Analyst

Rochester Regional Health

Remote

$100K - $130K/yr

Full-time

This job post has expired today. Applications are no longer accepted.

Rochester Regional Health rating

7.4

Company rating: 7.4 out of 10

Based on 212 frontline employees who took The Breakroom Quiz

256th of 873 rated healthcare providers

Job description

Job Title: Senior Clinical Trials IT Business Analyst
Department: Information Technology
Location: Remote
Hours Per Week: 40
Schedule: Days; Monday - Friday
SUMMARY
The Senior Clinical Trials IT Business Analyst (Sr. CT IT BA) serves as a strategic liaison between Clinical Development and Information Technology. This role leads the analysis, design, implementation, and optimization of clinical trial technology solutions to support global clinical research operations.
REPONSIBILITIES
  • Business & Technical Analysis: Obtain, analyze, and document detailed business, functional, and technical requirements, translate clinical / non-clinical operational needs into system configurations and technical solutions, develop Business Requirements Documents (BRDs), functional specifications, user stories & acceptance criteria, business process flow diagrams, and data flow diagrams, conduct system impact assessments and gap analyses, support system integration design across enterprise platforms.
  • Systems Implementation & Lifecycle Management: lead or support implementation, upgrade, enhancements, optimization and maintenance of Lab Information Management Systems (LIMS), Lab Information Systems (LIS), Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks (ELM), Validation Lifecycle Management (VLM), configure and support system enhancements, oversee vendor coordination and technical solution delivery, support the management of system change requests and release management processes.
  • Validation & Compliance (GxP): support Computer System Validation (CSV) and / or Computer System Assurance (CSA) activities such as validation plans, risk assessments, IQ/OQ/PQ test script development/documentation, user requirements & documentation, support the development of System Management Plan (SMP), Trace Matrix and other validation documentation as required, ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, MOH, participate in audit and inspection readiness efforts.
  • Integration & Data Management: collaborate with IT architecture teams on system integrations (APIs, HL7, middleware), ensure data integrity, traceability, and consistency across platforms, support data migration, master data governance, and reconciliation processes, partner with operational teams to define reporting requirements.
  • Testing & Deployment: lead User Acceptance Testing (UAT), develop test scripts, coordinate execution, support the manage defect tracking & resolution, support regression testing and release validation, facilitate system deployment and post-go-live support.
  • Stakeholder & Project Engagement: act as primary IT liaison for Clinical business stakeholders. facilitate workshops and requirements sessions, support Agile, PMBOK, or hybrid project methodologies, contribute to project plans, risk logs, and status reporting, provide training and change management support.

REQUIRED QUALIFICATIONS
  • Bachelor's degree in Life Sciences, Information Systems, Computer Science, or related field.
  • 3 years of experience in clinical research and/or clinical IT systems (i.e STARLIMS Life Sciences)
  • 3 years in Business Analysis within regulated (GxP) environments.

PREFERRED QUALIFICATIONS
  • Master's degree (MBA, MS, MPH, MHA) preferred.
  • CBAP, PMI-PBA, PMP, or Agile certifications.
  • Experience in global clinical trial environments.
  • Knowledge of CDISC, SDTM, and clinical data standards.
  • Experience with reporting tools (Power BI, Tableau, Qlik, Other).Familiarity with cloud-based clinical systems (e.g., Veeva, Medidata, Oracle Clinical, BioClinical, etc.).
  • Strong understanding of the lab clinical trial lifecycle.
  • Hands-on experience with LIMS/LIS clinical platforms (i.e STARLIMS Life Sciences)
  • Experience with system validation and regulatory compliance.
  • Familiarity with system integrations and data workflows.
  • Strong analytical and systems-thinking mindset
  • Technical fluency in enterprise applications
  • Regulatory compliance expertise
  • Cross-functional leadership
  • Vendor management skills
  • Excellent communication and documentation skills

EDUCATION:
LICENSES / CERTIFICATIONS:
PHYSICAL REQUIREMENTS:
S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.
Any physical requirements reported by a prospective employee and/or employee's physician or delegate will be considered for accommodations.
PAY RANGE:
$100,000.00 - $130,000.00
CITY:
Rochester
POSTAL CODE:
14624
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.

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