CSV Engineer / Senior CSV Engineer Singapore
Core
Execute Computerized System Validation (CSV) lifecycle activities, equipment qualification (IQ/OQ/PQ), and compliance reporting for GMP-regulated pharmaceutical systems.
Role type
Senior IC CSV Engineer (pharma/life sciences)
Builds
Validated computerized systems (MES, automation, lab, equipment) for pharmaceutical manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing / GMP Compliance
Required skills
Computerized System Validation (CSV), Equipment Qualification (IQ/OQ/PQ), GMP compliance, FDA 21 CFR Part 11, GAMP 5, MES validation, automation validation, lab system validation, deviation/change control management, e-validation tools (e.g., Kneat)
Preferred skills
Leadership of cross-functional validation teams, managing global projects, stakeholder management
Technologies
Kneat, MES, automation systems, lab systems
Responsibilities
Execute CSV lifecycle activities across MES, automation, lab, and equipment systems; Author, review, and approve validation protocols, test scripts, and compliance reports; Lead CSV/CQV strategy including deviation and change control; Collaborate with QA, Engineering, and Operations to ensure GMP compliance; Mentor junior engineers and manage cross-functional validation teams
Seniority
Senior, hands-on IC