Computer system validation - CSV/ CSA Engineer

Pharmatek Consulting Inc.; United States; Remote; USD 90,000 - 150,000; Full time

Benefits offered by this job

Remote work option

Job summary

Pharmatek Consulting Inc. is seeking a Computer System Validation (CSV/CSA) Engineer to execute validation activities in regulated environments in line with SDLC and quality expectations.

You will collaborate with global teams, review validation artifacts, and contribute to lifecycle deliverables, with preferred exposure to SAP and ALCOA+ principles.

Qualifications

• 4–5+ years in CSV/CSA or regulated system validation support.
• Working knowledge of validation lifecycle documentation and SDLC processes.
• Experience reviewing test artifacts, requirements traceability, and change controls.
• Ability to operate effectively in a remote, globally distributed team.
• Preferred exposure to SAP or enterprise platform validation.
• Preferred familiarity with GxP documentation practices and ALCOA+ principles.
• Preferred experience supporting validation execution within life sciences.

Responsibilities

• Execute CSA and validation activities in accordance with SDLC procedures and quality expectations
• Assist in preparation of validation plans, functional risk assessments, and traceability matrices
• Support review of validation/testing documentation and change control artifacts
• Contribute to validation summary reporting and lifecycle compliance deliverables
• Provide support for CMDB management and validation tool usage as needed
• Collaborate with Digital Quality, System Owners, and Business stakeholders throughout execution

Skills

CSV/CSA validation

SDLC processes

Documentation review

Traceability

Remote collaboration

Tools

SAP

ALCOA+

Job description

Computer system validation - CSV/ CSA Engineer

• Execute CSA and validation activities in accordance with SDLC procedures and quality expectations
• Assist in preparation of validation plans, functional risk assessments, and traceability matrices
• Support review of validation/testing documentation and change control artifacts
• Contribute to validation summary reporting and lifecycle compliance deliverables
• Provide support for CMDB management and validation tool usage as needed
• Collaborate with Digital Quality, System Owners, and Business stakeholders throughout execution

Requirements

• 4–5+ years in CSV/CSA or regulated system validation support
• Working knowledge of validation lifecycle documentation and SDLC processes
• Experience reviewing test artifacts, requirements traceability, and change controls
• Ability to operate effectively in a remote, globally distributed team
• Preferred exposure to SAP or enterprise platform validation
• Preferred familiarity with GxP documentation practices and ALCOA+ principles
• Preferred experience supporting validation execution within life sciences