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Work From Home Computer System Validation Csv Jobs

Tempus

Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... Develop and maintain CSV policies, procedures, templates and work instructions. * Lead risk-based ...

Genovice

CSV Validation Engineer

Atlanta, GA · Remote

$90K - $125K/hr

This role is distinct from independent Quality oversight. The Senior CSV Validation Engineer will ... System and intended-use descriptions * User requirements specifications * Functional and ...

Care Access

Computer Systems Validation Engineer

OR · On-site +1

$80K - $120K/yr

How This Role Makes a Difference The Computer System Validation Engineer is responsible for ... The CSV Engineer partners with Quality Assurance, Information Technology, Clinical Operations, and ...

Lonza

Director, Automation

Walkersville, MD · On-site +1

$203K - $237K/yr

Strong understanding of GMP regulations, Computer System Validation (CSV), GAMP 5 principles, data ... work we want you to be part of. Innovation thrives when people from all backgrounds bring their ...

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How much do work from home computer system validation csv jobs pay per hour?

As of Sep 15, 2026, the average hourly pay for work from home computer system validation csv in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.

What is a Work From Home Computer System Validation CSV?

A Work From Home Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals or healthcare, comply with regulatory requirements like FDA 21 CFR Part 11 and EU Annex 11. Professionals in this role create validation documentation, execute system testing, and assess compliance risks remotely. They work with teams to validate software, databases, and IT systems to ensure data integrity and regulatory adherence. This job requires knowledge of validation protocols, industry regulations, and software testing methodologies. Working from home, CSV professionals use virtual collaboration tools to perform their duties efficiently.

What are the typical daily responsibilities of a Work From Home Computer System Validation CSV specialist?

As a remote Computer System Validation CSV specialist, your daily tasks usually include preparing validation protocols, executing test scripts, reviewing documentation for compliance, and collaborating with cross-functional teams via digital platforms. You’ll be responsible for ensuring that computer systems adhere to regulatory requirements throughout their lifecycle by documenting evidence, addressing deviations, and supporting audits or inspections. The role often involves independent work, regular updates with project teams, and close coordination with IT, QA, and business stakeholders. This dynamic environment requires strong organizational skills and adaptability to ensure timely, compliant, and quality results from a remote setting.

What are the key skills and qualifications needed to thrive in the Work From Home Computer System Validation CSV position, and why are they important?

To excel as a Work From Home Computer System Validation (CSV) specialist, you need a solid background in IT or life sciences, a deep understanding of validation principles, and experience with regulatory guidelines such as FDA 21 CFR Part 11 and GxP. Familiarity with validation management software, documentation tools, and electronic quality management systems (eQMS) is often required, along with certifications like PMP or ISPE when applicable. Strong attention to detail, self-motivation, excellent written communication, and the ability to collaborate virtually are key soft skills for remote success. These skills ensure compliance, high-quality deliverables, and effective teamwork in a regulated, remote work environment.

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Work From Home Computer System Validation Csv jobs near you
Infographic showing various Work From Home Computer System Validation Csv job openings in the United States as of September 2026, with employment types broken down into 87% Full Time, and 13% Contract. Highlights an 100% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Senior Manager, Computer System Validation QA

Remote

BridgeBio Pharma
Biotechnology Research and Development • 201 - 500 employees
Learn more about BridgeBio Pharmaexternal

Full-time

Posted 3 days ago

New

Job description

Who You Are

The Senior Manager, Computer System Validation (CSV), QA will report to the Sr. Director, QA Ops and Inspection Management. This position will provide quality oversight of the computer system validation lifecycle from design and implementation to retirement, ensuring compliance of GxP applications. This role will ensure that all GCP/GVP computerized systems are validated for intended use, and maintained in compliance with Health Authority requirements.

This position partners cross-functionally with IT, GMP Quality Assurance, and functional area system owners, business process owners, and service providers to apply a documented, risk-based approach to validation and compliance.

Responsibilities

  • Provide QA oversight of the GCP/GVP computer system validation lifecycle, ensuring ongoing compliance and a validated state through design, configuration, updates, and maintenance.
  • Review and approve computer system risk assessments to determine the scope and level of validation required for system implementation.
  • Review and approve IT change control and validation deliverables, including protocols, test scripts, and reports of the GCP/GVP validated system.
  • Participate, review, and approve periodic system and user reviews, identifying and remediating compliance gaps.
  • Collaborate with IT and cross-functional stakeholders such as business owners, to establish and enforce requirements for system validation, data integrity, and ongoing system maintenance.
  • Support the computer system audit program by participating in audit activities including audit report and CAPA reviews.
  • Project manage the implementation, configuration, and continuous enhancement of GCP/GVP and QMS computer systems.
  • Drive continuous improvement initiatives for QMS and validated GxP systems.
  • Support inspection readiness and regulatory inspection activities including serving as a QA CSV subject matter expert and response/CAPA management through timely resolution and closure.
  • Review and approve GxP-computer system and business process procedures, and support end-user training to ensure proper adoption and compliance.
  • Support organizational artificial intelligence (AI) governance as the GCP/GVP Quality representative

 
Education, Experience & Skills Requirements

  • Bachelor's or Master's degree in software, computer engineering, or technical field.
  • 8+ years of experience in quality systems development and maintenance within clinical and commercial-stage pharmaceutical or biotech companies.
  • Excellent attention to detail and strong organizational skills.
  • Effective communication skills both written and verbal.
  • Demonstrated expertise in GxP computerized system validation/assurance (CSV/CSA) and system lifecycle management.
  • Working knowledge of applicable electronic-record, computerized-system, data-integrity, clinical-practice, and pharmacovigilance requirements and guidance, including 21 CFR Part 11, relevant FDA predicate rules, EU Annex 11 principles, ICH GCP, EU GVP, and risk-based lifecycle practices such as GAMP.
  • Experience developing GxP SOPs and training personnel on compliance requirements.
  • Experience with Artificial Intelligence (AI)/ Large Language Models (LLMs) and AI Governance in a GxP setting is a plus.
  • Ability to work independently and collaboratively within a team.
  • Ability to influence and drive cross-functional teams.
  • Travel into the San Francisco office quarterly for remote employees.

Apply