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Computer System Validation Technical Writer Jobs

Inteldot

Excellent technical writing and documentation skills. * Strong communication and cross-functional ... Computer System Validation (CSV) * GAMP 5 * 21 CFR Part 11 * cGMP/FDA Compliance * IQ/OQ/PQ ...

ClifyX

Computer system Validation Tester

Somerset, NJ · On-site

... SOPs, writing scripts for IQ, OQ, PQ and handling CSV • Help, guide and direct the project ... Required : • Computer System Validation • Life cycle • Process Validation • Risk Assessment ...

Jubilant Pharma, LLC

$91K - $147K/yr

Write and review documents to support the qualification of a computerized system. * Validation Plan ... Experience with technical writing, building and manufacturing computer control processes/systems.

Soltech PR

$60 - $80/hr

The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle ... Strong technical writing, documentation, analytical, and problem-solving skills. * Ability to work ...

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How much do computer system validation technical writer jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for computer system validation technical writer in the United States is $38.94, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $47.12 per hour, depending on experience, location, and employer.

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Infographic showing various Computer System Validation Technical Writer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, and 3% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Senior Computer System Validation (CSV) Engineer - Consultant

On-site

Inteldot
See more jobs at Inteldotexternal

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Re-posted 2 days ago

Job description

Position Summary

We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ideal candidate will have extensive experience validating computerized systems within the pharmaceutical or biotechnology industry and hands-on experience with Emerson DeltaV automation systems. The successful candidate will work closely with Engineering, Automation, Manufacturing, Quality Assurance, and IT teams to ensure computerized systems are validated and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 requirements.

Location: Texas (Onsite)

Administrative shiftResponsibilities
  • Lead Computer System Validation (CSV) activities for GMP computerized systems.
  • Develop, review, and execute validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
  • Validate automation systems, including Emerson DeltaV DCS, SCADA, and supporting infrastructure.
  • Support commissioning and qualification activities for new and existing manufacturing systems.
  • Perform impact assessments, change control evaluations, and periodic reviews.
  • Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements.
  • Collaborate with Automation, Engineering, IT, Manufacturing, and Quality teams during project execution.
  • Support audits and regulatory inspections by providing validation documentation and technical expertise.
  • Review system lifecycle documentation and maintain validated system status.
Required Qualifications
  • Bachelor’s degree in engineering, Computer Science, Information Systems, or related technical discipline.
  • 5+ years of Computer System Validation experience in the pharmaceutical, biotechnology, or medical device industry.
  • Hands-on experience validating Emerson DeltaV systems is required.
  • Strong understanding of GAMP 5, FDA regulations, cGMP, and 21 CFR Part 11.
  • Experience developing and executing IQ, OQ, and PQ protocols.
  • Experience with change control, deviation investigations, CAPA, and risk assessments.
  • Excellent technical writing and documentation skills.
  • Strong communication and cross-functional collaboration skills.
Preferred Qualifications
  • Experience with Manufacturing Execution Systems (MES), SCADA, PLCs, or process automation systems.
  • Knowledge of electronic batch records (EBR) and manufacturing systems integration.
  • Experience supporting commissioning, qualification, and validation (CQV) projects in biologics or sterile manufacturing environments.
Technical Skills
  • Emerson DeltaV (Required)
  • Computer System Validation (CSV)
  • GAMP 5
  • 21 CFR Part 11
  • cGMP/FDA Compliance
  • IQ/OQ/PQ Protocols
  • Risk Assessments
  • Change Control
  • CAPA
  • Commissioning & Qualification (CQV)
  • Automation Systems Validation
  • Technical Documentation
Preferred Industry Experience
  • Biotechnology
  • Pharmaceutical Manufacturing
  • GMP-Regulated Facilities
  • Cell & Gene Therapy or Biologics Manufacturing (preferred)
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