Senior CSV Engineer

Job Description & Requirements

Job Purpose

To lead and execute end-to-end Computer System Validation (CSV) activities for DeltaV automation systems in pharmaceutical manufacturing, ensuring full compliance with GMP, 21 CFR Part 11, EU Annex 11, and PIC/S requirements.

Key Responsibilities
DeltaV Validation Lifecycle Leadership

Review and approve DeltaV Functional Specification (FS) and Design Specification (DS) for GMP-critical systems.

Prepare, execute, and approve validation protocols:

Software Installation Qualification (SIQ)

Input/Output (I/O) Loop Check Protocols

Functional/Design Qualification (FQ/DQ) as required

Conduct pre-execution and post-execution reviews of all CSV protocols.

Compliance & Documentation
Approve automation change controls, including risk assessments (GAMP 5, FMEA).

Ensure adherence to data integrity principles and electronic record/electronic signature (ERES) requirements...