Senior CSV/CSA Validation Specialist - Pharma Systems

WaveCrest Staffing Group; Newark (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

WaveCrest Staffing Group seeks a Validation SME in California to support validation of computerized systems, equipment, and instruments in a pharma/biotech setting. You will maintain existing validated systems, support change control, and data integrity assessments.

Responsibilities include coordinating periodic reviews, authoring lifecycle documentation, managing qualification and testing activities (OQ/UAT), reviewing test packages, and supporting system owners throughout the lifecycle.

Qualifications

• Bachelor's degree in a scientific discipline.
• 6–8 years of qualification/validation experience in pharma/biotech.
• Experience with CSV and/or CSA.
• Experience validating ERP, LIMS, MES, and/or DMS systems.
• Strong technical writing skills.
• Knowledge of 21 CFR Part 11, GAMP 5, MHRA Data Integrity Guidelines.
• SAP change management is a plus.

Responsibilities

• Coordinate and support routine periodic system reviews.
• Author and develop system lifecycle documentation (risk assessments, user requirements, test protocols).
• Coordinate, manage, and execute qualification and testing activities (OQ and UAT).
• Review completed test packages and address exceptions.
• Support system owners and stakeholders through system lifecycle activities.
• Coordinate and support data integrity assessments.
• Ensure electronic records and data integrity compliance.
• Lead or support system change control processes.
• Troubleshoot and resolve complex system issues.

Skills

CSV/CSA experience

Education

Bachelor's degree in a scientific discipline

Tools

ERP

LIMS

MES

DMS

SAP change management

Job description

WaveCrest Staffing Group seeks a Validation SME in California to support validation of computerized systems, equipment, and instruments in a pharma/biotech setting. You will maintain existing validated systems, support change control, and data integrity assessments.

Responsibilities include coordinating periodic reviews, authoring lifecycle documentation, managing qualification and testing activities (OQ/UAT), reviewing test packages, and supporting system owners throughout the lifecycle.