Computer Systems Validation Specialist

Katalyst-Healthcares-; Newark (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst-Healthcares- in Newark, CA seeks an experienced Computer Systems Validation Specialist to lead validation efforts for computerized systems, ERP, LIMS, and MES within a highly regulated life sciences environment. You will develop validation strategies, write protocols, and coordinate OQ/UAT testing across IT, engineering, QA, and manufacturing teams.

The ideal candidate has 6–8 years in pharmaceutical/biotech validation, familiarity with 21 CFR Part 11 and GAMP 5, and strong data

Qualifications

• 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.

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.

Skills

CSV validation

Documentation

Risk assessment

Test planning

Change control

Education

Bachelor's degree in a scientific or technical discipline

Experience with CSV/CSA

Tools

ERP systems

LIMS

MES

Document management

Job description

Summary:

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.

Roles and 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.

Education and Experience:

• 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.