CSV Automation Engineer - Katalyst Healthcares & Life Sciences

Holly Springs, NC 27540

About the Job

Responsibilities:

Software Factory Acceptance Test (sFAT) (QA Oversight).
Automation Commissioning Test Plans (ACTPs).
Software Operational Qualification (sOQ).
Automation Change Assessments (ACAs).
Design Reviews and Design Qualifications (DR and DQ).
Requirement Traceability Matrix (RTM).
Functional Specifications (FS), Platform Requirement Specifications (PRS).
Protocol Deviation Resolutions (Kneat Issues).

Requirements:

DeltaV Experience (Must).
Validation Experience (Must).
QA Experience (Must).
Willing and Able to work Nights/Weekends (MUST).
Greenfield Project Experience (Preferred).
Senior Level (5-8+, 10+ ideal).
Understanding of System Integrators/Code Configuration.
Prior use and familiarity with Electronic validation systems, e.g. KNEAT Gx.
GAMP5, ALCOA++, Data Integrity.

Source : Katalyst Healthcares & Life Sciences

Job summary