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Biotech Csv Jobs (NOW HIRING)

Forge Biologics

CSV Engineer I

Columbus, OH

We partner with scientists, physicians, biotech and pharma innovators, and patient communities ... The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are ...

Workforce Genetics

CSV Engineer

Baltimore, MD · On-site

CSV Engineer (6mo. Contract-to-Hire) Location: Baltimore, MD Company Join a premier global Contract ... This organization is a strategic partner to leading pharmaceutical and biotech companies ...

Forge Biologics

CSV Engineer I

Columbus, OH · On-site

We partner with scientists, physicians, biotech and pharma innovators, and patient communities ... The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are ...

Proven Recruiting

Material Manager - Biotech

San Diego, CA · On-site

$100K - $130K/yr

Our client, an innovative biotech company, is seeking a hands-on leader to drive ERP implementation ... Experience with validation (CSV), UAT, audits, and quality systems within a QMS What you'll do:

PSC Biotech

CA

PSC Biotech provides the life sciences with essential services to ensure that health care products ... Validation & CSV Support Support Computer System Validation (CSV) activities for LabWare ...

KBI Biopharma, Inc.

CSV Specialist II

Durham, NC · On-site

Bachelor's degree in Engineering, Information Technology, or a related discipline. * 3-5 years of experience as a CSV Specialist or in a comparable role within the pharmaceutical or biotechnology ...

KBI Biopharma, Inc.

CSV Specialist II

Durham, NC · On-site

Bachelor's degree in Engineering, Information Technology, or a related discipline. * 3-5 years of experience as a CSV Specialist or in a comparable role within the pharmaceutical or biotechnology ...

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Biotech Csv information

What are some common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

What are Biotech CSV professionals?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are the key skills and qualifications needed to thrive as a Biotech CSV (Computer System Validation) Specialist, and why are they important?

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.
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Biotech Csv jobs near you
Infographic showing various Biotech Csv job openings in the United States as of July 2026, with employment types broken down into 91% Full Time, 1% Part Time, 1% Temporary, and 7% Contract. Highlights an 81% Physical, 3% Hybrid, and 16% Remote job distribution.

CSV Consultant (Computer System Validation)

Stark Pharma Solutions Inc

Redwood City, CA • On-site

Contractor

Posted 10 days ago

Job description

Job Title: CSV Consultant (Computer Systems Validation)

Location: Redwood City, CA

Type: Contract

Job Summary

We are seeking an experienced CSV Consultant to support validation activities across multiple GxP-regulated systems within a pharmaceutical environment. This role will focus on computer systems validation, revalidation efforts, data migration activities, and documentation management for critical business and quality systems.

The ideal candidate will have strong experience with validated systems, change control processes, and regulatory compliance in GMP/GxP environments.

Key Responsibilities

  • Lead and support validation activities for GxP-regulated systems including:
  • SAS Studio
  • Veeva Quality Docs
  • CTMS
  • TraceLink
  • Argus
  • Support system revalidation and data migration projects to ensure compliance and data integrity
  • Develop, review, and execute validation documentation including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Risk Assessments
  • IQ/OQ/PQ protocols
  • Traceability Matrices
  • Summary Reports
  • Create and support User Acceptance Testing (UAT) scripts and execution activities
  • Manage change control documentation and support deviation resolution activities
  • Ensure validation activities align with FDA, GAMP5, and GxP compliance requirements
  • Collaborate with IT, Quality, Clinical, and Business stakeholders to support validated system implementations and updates
  • Maintain accurate and compliant documentation throughout the system lifecycle

Required Qualifications

  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
  • 5+ years of experience in Computer Systems Validation (CSV) within pharmaceutical or biotech environments
  • Hands-on experience validating GxP systems and supporting regulated system implementations
  • Strong knowledge of FDA 21 CFR Part 11, GAMP5, and GxP requirements
  • Experience with validation documentation, UAT execution, and change control processes
  • Familiarity with systems such as SAS Studio, Veeva, CTMS, TraceLink, or Argus
  • Strong analytical, documentation, and communication skills