Dawar Consulting
Dawar Consulting

60 Dawar Consulting Jobs Hiring Near You

$58/hr

Executive Administrative Business Partner (ABP) - Population Health, Customer Engagement (Remote) Our client, a world leader in life sciences and biotechnology, is looking for an Executive ...

Histology Associate

Tucson, AZ ยท On-site

$25/hr

Histology Associate Our client, world leader in life sciences and medical diagnostics, is looking for a Histology Associate based out of Tucson, AZ. Kindly look at the details below and let me know ...

ITOT Support Engineer Our client, a world leader in the life sciences and diagnostics industry, is looking for an IT/OT Support Engineer in Hillsboro, OR. Duration: Long Term Contract PR: $60/hr on ...

Data Coordinator II Our client, a world leader in diagnostics and life sciences, is looking for a Data Coordinator II based out of Santa Clara, CA. Job Duration: Long term Contract (Possibility Of ...

Our client, a world leader in biotechnology and life sciences, is looking for a " Validation Engineer " based out in Tucson, AZ. Job Duration: Long Term Contract (Possibility Of Extension & FT ...

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Infographic showing various job openings at Dawar Consulting in the United States as of May 2026, with employment types broken down into 94% Full Time, 2% Part Time, and 4% Nights. Highlights an 82% Physical, 11% Hybrid, and 7% Remote job distribution.
Senior Computer System Validation (CSV) Consultant

Senior Computer System Validation (CSV) Consultant

Dawar Consulting, Inc.

San Diego, CA

$75 - $85/hr

Full-time

Medical, Dental, Vision, Retirement

Posted 17 days ago


Job description

Our client, a world leader in biotechnology and life sciences, is looking for a โ€œSenior Computer System Validation (CSV) Consultantโ€ based out of San Diego, CA.

Job Duration: Long Term Contract (Possibility Of Extension)
Pay Rate: $75/hr - $85/hr on W2 DOE
Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

We are seeking an experienced Senior Computer System Validation (CSV) Consultant to support and enhance the siteโ€™s Computer System Validation program. This role provides Quality Assurance oversight for computerized systems used across laboratory, manufacturing, and quality operations, ensuring compliance with global regulatory standards. Reporting to the Site Quality Head, the consultant will lead validation activities throughout the system lifecycle and ensure systems remain inspection-ready.

Key Responsibilities:
ยท Lead and support the computer system validation lifecycle for GxP systems.
ยท Author, review, and approve validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
ยท Conduct system requalification and periodic reviews to maintain validated system status.
ยท Ensure computerized systems comply with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
ยท Serve as the Quality Lead for validation projects, guiding teams through system implementation and validation activities.
ยท Partner with cross-functional teams including IT, Engineering, Manufacturing, QC, and Quality to ensure compliant system design and deployment.
ยท Provide guidance on data integrity, security controls, and risk-based validation approaches.
ยท Review and approve system lifecycle documentation to ensure compliance with SOPs and regulatory requirements.
ยท Support internal audits and regulatory inspections (FDA/EMA).

Qualifications
ยท Bachelorโ€™s degree in Life Sciences, Engineering, Computer Science, or related field.
ยท 8+ years of experience in Computer System Validation within the life sciences or regulated industry.
ยท Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity (ALCOA+).
ยท Experience with GxP systems such as EDMS, LMS, LIMS, and MES.
ยท Familiarity with Quality systems including Change Control, Deviations, CAPA, and Document Management.


If interested, please send us your updated resume at hr@dawarconsulting.com/lakshmi@dawarconsulting.com