Job Description

Job Duration: Long Term Contract (Possibility Of Extension)

Pay Rate : $70/hr - $78/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 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.

Key Responsibilities:

Validation & Compliance

· Lead and support the computer system validation lifecycle for GxP systems.

· Author, review, and approve validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.

· Conduct system requalification and periodic reviews to maintain validated system status.

· Ensure computerized systems comply with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

Project Leadership & Collaboration

· Serve as the Quality Lead for validation projects, guiding teams through system implementation and validation activities.

· Partner with cross-functional teams including IT, Engineering, Manufacturing, QC, and Quality to ensure compliant system design and deployment.

· Provide guidance on data integrity, security controls, and risk-based validation approaches.

Audit & Operational Support

· Review and approve system lifecycle documentation to ensure compliance with SOPs and regulatory requirements.

· Support internal audits and regulatory inspections (FDA/EMA).

· Identify compliance gaps, perform risk assessments, and support CAPA implementation.

System Oversight & Continuous Improvement

· Evaluate and assess legacy systems for compliance and integration.

· Support improvements to validation processes and quality compliance procedures.

· Maintain reports on system compliance status and validation progress.

Qualifications

· Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.

·8+ years of experience in Computer System Validation within the life sciences or regulated industry.

· Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity (ALCOA+).

· Experience with GxP systems such as EDMS, LMS, LIMS, and MES.

· Familiarity with Quality systems including Change Control, Deviations, CAPA, and Document Management.

· Strong analytical, documentation, and cross-functional collaboration skills.

If interested, please send us your updated resume at

hr@dawarconsulting.com akansha@dawarconsulting.com

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