Lab System Validation Engineer — CSV & GMP Expert

Katalyst CRO; Rahway (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO seeks a skilled CSV Validation professional to drive validation of laboratory and enterprise systems in a GMP/GCP setting. You will develop and execute validation deliverables across equipment, facilities and computerized systems, aligning with CSA, SDLC and V-model practices.

Ideal candidates have pharma domain expertise, strong technical writing, and familiarity with regulatory standards such as 21 CFR Part 11 and Annex 11. Collaboration with QA, IT, and Lab teams is essential.

Qualifications

• Experience with CSV Validation in Lab systems and GAMP 5 guidance.
• US FDA 21 CFR Part 11, EU Annex 11 familiarity is required.
• Must have pharmaceutical domain knowledge and related regulatory exposure.
• Strong technical writing and validation documentation skills.

Responsibilities

• Develop validation documentation for pharmaceutical equipment, facilities and computerized systems in GLP, GMP and GCP environments.
• Prepare and execute URS, MVP, VP, RTM, IQ, OQ, PQ, VSR and Traceability Matrix artifacts.
• Lead CSV validation efforts, provide guidance on compliance and quality management.
• Deliver validation plans, specifications, test protocols and SOPs; work with QA, IT and Lab teams.
• Support regulatory audits and remediation activities; ensure artefacts meet regulatory requirements.

Skills

CSV validation

Pharma domain knowledge

Regulatory compliance

Technical writing

Agile development

Tools

Jira

ServiceNow

Client ALM

Job description

Katalyst CRO seeks a skilled CSV Validation professional to drive validation of laboratory and enterprise systems in a GMP/GCP setting. You will develop and execute validation deliverables across equipment, facilities and computerized systems, aligning with CSA, SDLC and V-model practices.

Ideal candidates have pharma domain expertise, strong technical writing, and familiarity with regulatory standards such as 21 CFR Part 11 and Annex 11. Collaboration with QA, IT, and Lab teams is essential.