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Senior Computer System Validation (CSV) Consultant

Dawar Consulting

San Diego, California

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Change Control, Code of Federal Regulations, Computer Science, Computer Skills, Computer Systems, Consulting, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Quality, Document Management, FDA (Food and Drug Administration), FDA Requirements, GxP, Information Technology & Information Systems, Information/Data Security (InfoSec), Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Operations, People Management, Process Validation, Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Reports, Risk Analysis, Risk Management, System Lifecycle, System Validation, Systems Maintenance, Traceability, Validation Documentation, Validation Plan, Writing Skills
LOCATION
San Diego, California
POSTED
9 days ago
Our client, a world leader in biotechnology and life sciences, is looking for a “Senior Computer System Validation (CSV) Consultant<\/b>” based out of San Diego, CA<\/b>.
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Job Duration:<\/b> Long Term Contract (Possibility Of Extension)
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Pay Rate:<\/b> $75/hr - $85/hr on W2 DOE 
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Company Benefits:<\/b> Medical, Dental, Vision, Paid Sick leave, 401K
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We are seeking an experienced Senior Computer System Validation (CSV) Consultant to support and enhance the site’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.
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Key Responsibilities:<\/b>
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·       Lead and support the computer system validation lifecycle for GxP systems.
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·       Author, review, and approve validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
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·       Conduct system requalification and periodic reviews to maintain validated system status.
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·       Ensure computerized systems comply with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
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·       Serve as the Quality Lead for validation projects, guiding teams through system implementation and validation activities.
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·       Partner with cross -functional teams including IT, Engineering, Manufacturing, QC, and Quality to ensure compliant system design and deployment.
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·       Provide guidance on data integrity, security controls, and risk -based validation approaches.
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·       Review and approve system lifecycle documentation to ensure compliance with SOPs and regulatory requirements.
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·       Support internal audits and regulatory inspections (FDA/EMA).
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Qualifications<\/b>
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·       Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
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·       8+ years of experience in Computer System Validation within the life sciences or regulated industry.
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·       Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity (ALCOA+).
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·       Experience with GxP systems such as EDMS, LMS, LIMS, and MES.
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·       Familiarity with Quality systems including Change Control, Deviations, CAPA, and Document Management. 
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If interested, please send us your updated resume at

hr@dawarconsulting.com

lakshmi@dawarconsulting.com

About the Company

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Dawar Consulting

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