Computer Systems Validation Specialist

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

We are seeking an experienced Computer Systems Validation Specialist to support validation and compliance activities within a highly regulated life sciences manufacturing environment. This individual will be responsible for supporting the qualification and validation of computerized systems, equipment, and instrumentation while ensuring systems remain compliant throughout their operational lifecycle.

The position will involve a combination of validation documentation, system testing, risk assessments, change management, and data integrity initiatives. The ideal candidate will have a strong background in pharmaceutical or biotechnology validation and the ability to independently manage projects and work cross-functionally.

Key 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 ensure discrepancies are appropriately resolved.
• 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 their impact on validated systems.
• Support regulatory compliance initiatives related to electronic records, system security, and data integrity.
• Troubleshoot validation-related issues and coordinate appropriate corrective actions.
• Develop testing strategies and ensure validation activities are completed accurately and within established timelines.

Required Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 6-8 years of experience in validation or qualification within the pharmaceutical, biotechnology, or life sciences industry.
• Experience with Computer System Validation (CSV) and/or Computer Software Assurance (CSA).
• Previous experience validating enterprise or manufacturing systems such as ERP, LIMS, MES, or document management systems.
• Strong technical writing and validation documentation experience.
• Knowledge of 21 CFR Part 11, GAMP 5, and applicable data integrity requirements.
• Experience with change control, risk assessments, and system impact assessments.
• Background developing validation strategies, test plans, and qualification protocols.
• Strong organizational, analytical, and problem-solving skills.
• Ability to independently manage multiple priorities and meet project deadlines.

Preferred Qualifications:

• Experience supporting SAP systems or SAP-related change management activities.
• Experience working with cross-functional technical and business teams.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!