CSV Engineer

Roles & Responsibilities

We are seeking an experienced CSV Engineer to support validation of computerized systems in a GMP-regulated pharma environment. The role involves developing and executing validation deliverables, ensuring compliance with 21 CFR Part 11, Annex 11, GAMP 5 , and collaborating with cross-functional teams for successful project delivery.

Key Responsibilities

• Develop and execute validation plans, test plans, and qualification protocols ( IQ, OQ, PQ, PPQ ) for lab, manufacturing, and automation systems.
• Perform CSV deliverables including URS, risk assessments, traceability, and test scripts.
• Ensure compliance with data integrity (ALCOA+), 21 CFR Part 11, and GMP guidelines .
• Manage change control, deviations, CAPA, and risk assessments (pFMEA / dFMEA) .
• Coordinate with QA, QC, IT, and Engineering for validation activities and project timelines.
• Maintain accurate documentation for audits and regulatory inspections.
• Apply GAMP 5, V-Model, and Agile methodologies in validation lifecycle.

Qualifications & Skills

Tell employers what skills you have

DeltaV

Regulatory Compliance

GMP

FDA GMP

GAMP

PLC

Protocol

Biotechnology

data integrity

Automation

Life Sciences

c-GMP