CSV Engineer: GMP IT/OT Validation & Compliance

RoviSys; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

RoviSys is seeking a CSV Engineer to support client CSV strategy and validation activities for automation and IT/OT products at client sites, including local software qualification for global/core systems like MES.

Role involves collaborating across IT/OT, Quality, MSAT, and Manufacturing teams, maintaining lifecycle documentation, and authoring commissioning protocols in a GMP environment.

Qualifications

• Diploma or B.S. in Computer Science, Chemical Engineering, Electrical Engineering, or equivalent.
• Experience with IT/Automation system support in a biotech/pharmaceutical GMP environment is a plus.
• Familiarity with CSV activities is a plus.
• Strong team player able to thrive in a client-facing environment.
• Self-driven with strong verbal and written communication skills.

Responsibilities

• Generate CSV deliverables for product software and IT infrastructure during automation project execution.
• Collaborate with IT/OT, Quality, MSAT/Automation, Manufacturing, and Quality Control teams on assessments.
• Manage and maintain lifecycle documentation for validated systems.
• Author protocols for commissioning and qualification activities on client projects.
• Ensure adherence to client quality policies, GxP requirements, and SOPs, plus RoviSys internal standards.
• Apply GEP principles to validation and commissioning work.
• Follow client site SHE requirements and report hazards promptly.
• Observe site security protocols and report suspicious activity.
• Contribute to continuous improvement using Lean tools to drive efficiency in validation and delivery.

Skills

Verbal communication

Written communication

Team player

Client-facing

Self-motivated

Lean principles

Education

Diploma or B.S. in Computer Science, Chemical Engineering, Electrical Engineering, or equivalent

Tools

Siemens automation products

Octoplant

Job description

RoviSys is seeking a CSV Engineer to support client CSV strategy and validation activities for automation and IT/OT products at client sites, including local software qualification for global/core systems like MES.

Role involves collaborating across IT/OT, Quality, MSAT, and Manufacturing teams, maintaining lifecycle documentation, and authoring commissioning protocols in a GMP environment.