CSV Validation Engineer — GMP Automation & IT/OT

RoviSys; Singapore; Presencial; SGD 70.000 - 90.000; Jornada completa

Descripción de la vacante

RoviSys in Singapore seeks a CSV Engineer to support client CSV strategy and validation activities for automation and IT/OT products deployed on client sites, including local software instance qualification for global/core systems (e.g., MES).

You will collaborate with client IT/OT, Quality, MSAT/Automation, Manufacturing, and Quality Control teams on assessments, author protocols, and maintain lifecycle documentation, ensuring compliance with GMP, GxP, and company standards while applying GEP

Formación

• Diploma or B.S. in CS, Chemical, or Electrical engineering.
• Experience with IT/Automation systems in a GMP biotech/pharma environment is a plus.
• Familiarity with CSV activities.
• Strong teamwork and client-facing communication.
• Experience with AVEVA PI or MES is a plus.

Responsabilidades

• Work with the site CSV Lead and project teams to generate CSV deliverables for product software and IT infrastructure during automation project execution.
• Collaborate with client IT/OT, Quality, MSAT/Automation, Manufacturing, and Quality Control teams on assessments (System Impact, Criticality, Data Integrity, Audit Trail).
• Manage and maintain lifecycle documentation for validated systems.
• Author protocols for commissioning and qualification activities on client projects.
• Ensure all work adheres to client quality policies, GxP, SOPs, and internal standards.
• Apply good engineering practice (GEP) principles throughout validation work.
• Comply with client site and RoviSys SHE requirements; report hazards promptly.
• Observe client site security protocols and report any issues to security.
• Embed RoviSys’s continuous improvement culture using Lean tools to drive efficiency.

Conocimientos

Team player

Communication

Client-facing

Self-driven

Educación

Diploma or Bachelor's in Computer Science / Chemical Engineering / Electrical Engineering or equivalent

Herramientas

AVEVA PI

MES familiarity

Descripción del empleo

RoviSys in Singapore seeks a CSV Engineer to support client CSV strategy and validation activities for automation and IT/OT products deployed on client sites, including local software instance qualification for global/core systems (e.g., MES).

You will collaborate with client IT/OT, Quality, MSAT/Automation, Manufacturing, and Quality Control teams on assessments, author protocols, and maintain lifecycle documentation, ensuring compliance with GMP, GxP, and company standards while applying GEP