Life Sciences CSV Specialist: Validation & Compliance

WaveCrest Staffing Group; Newark (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

WaveCrest Staffing Group seeks an experienced Computer Systems Validation Specialist to support validation and compliance of computerized systems in a regulated life sciences manufacturing environment. You will qualify and validate systems, equipment, and instrumentation, and manage lifecycle compliance.

The role covers documentation, risk assessments, change management, data integrity initiatives, system testing (OQ/UAT), and collaboration with IT, quality, engineering, and business teams to

Qualifications

• Bachelor's degree in a scientific or technical field required.
• 6–8 years in validation or qualification within pharma/biotech.
• Experience with CSV and/or CSA concepts and methodologies.
• Experience validating enterprise/manufacturing systems (ERP/LIMS/MES).
• Strong validation documentation and technical writing skills.
• Knowledge of 21 CFR Part 11, GAMP 5, data integrity requirements.
• Experience with change control and risk assessments.
• Ability to manage multiple priorities and meet deadlines.

Responsibilities

• Support validation and qualification activities for computerized systems, manufacturing equipment, and instrumentation.
• Perform routine system assessments and periodic reviews to maintain compliance.
• Prepare and maintain validation documentation, including risk assessments, user requirements, and testing protocols.
• Coordinate and execute system testing activities, including OQ and UAT.
• Review testing documentation, investigate exceptions, and resolve discrepancies.
• Collaborate with IT, engineering, quality, and business teams throughout system implementation and lifecycle activities.
• Conduct data integrity assessments and identify potential compliance gaps.
• Manage system changes and evaluate impact on validated systems.
• Support regulatory compliance initiatives related to electronic records, system security, and data integrity.
• Troubleshoot validation-related issues and coordinate corrective actions.
• Develop testing strategies and ensure activities are completed on time.

Skills

CSV/CSA experience

Validation strategy

Documentation

System testing

Risk assessment

Change control

Data integrity

Cross-functional teamwork

Project management

Strong writing

Education

Bachelor's degree in a scientific/technical discipline

Tools

ERP

LIMS

MES

Document management systems

Job description

WaveCrest Staffing Group seeks an experienced Computer Systems Validation Specialist to support validation and compliance of computerized systems in a regulated life sciences manufacturing environment. You will qualify and validate systems, equipment, and instrumentation, and manage lifecycle compliance.

The role covers documentation, risk assessments, change management, data integrity initiatives, system testing (OQ/UAT), and collaboration with IT, quality, engineering, and business teams to