CSV Lab Systems Validation Specialist

TechDigital Group; Rahway (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

TechDigital Group seeks a technically adept validation professional in Rahway, NJ, to drive CSV program execution across laboratory and enterprise systems within GLP, GMP, and GCP contexts.

The role requires hands-on experience with CSV validation in lab environments, familiarity with FDA Part 11 and EU Annex 11, plus strong technical writing and cross-functional communication skills. Agile exposure and Jira/ServiceNow usage are advantages.

Qualifications

• Experience in CSV validation for lab systems in pharma or related domains.
• Familiarity with regulatory frameworks like 21 CFR Part 11 and GAMP 5.
• Strong technical writing and communication abilities.
• Ability to prepare validation artifacts such as URS, IQ/OQ/PQ, VSR, and traceability matrices.

Responsibilities

• Develop validation documentation for pharmaceutical equipment, facilities and computerized systems in GLP, GMP and GCP environments.
• Produce validation plans, specifications, test protocols and SOPs for processes including Process/Lab Automation and Enterprise IT.
• Provide guidance on Regulatory Compliance and Quality Management requirements.

Skills

CSV validation

GAMP 5

FDA Part 11 (US)

EU Annex 11

Pharmaceutical domain knowledge

Lab systems validation

Technical writing

Communication skills

Regulatory compliance

Agile development

Jira

ServiceNow

AI awareness

Tools

Jira

ServiceNow

ALM

Job description

TechDigital Group seeks a technically adept validation professional in Rahway, NJ, to drive CSV program execution across laboratory and enterprise systems within GLP, GMP, and GCP contexts.

The role requires hands-on experience with CSV validation in lab environments, familiarity with FDA Part 11 and EU Annex 11, plus strong technical writing and cross-functional communication skills. Agile exposure and Jira/ServiceNow usage are advantages.