CSV Automation Engineer

RoviSys; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Team player

Communication

Client-facing

Self-driven

Education

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

Tools

AVEVA PI

MES familiarity

Job description

RoviSys partners with biotech and pharmaceutical manufacturing clients to deliver automation, IT/OT integration, and computer system validation services. The CSV Engineer supports 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), local vendor product software qualification, and IT infrastructure (servers, workstations, network switches).

Key Responsibilities

• Work closely with the client's site CSV Lead and RoviSys project teams to generate CSV deliverables for product software and IT infrastructure during automation project execution, for systems supported by RoviSys.
• Collaborate with client IT/OT, Quality, MSAT/Automation, Manufacturing, and Quality Control teams on assessments such as System Impact Assessment, Criticality Assessment, Data Integrity Assessment, and Audit Trail Assessment.
• Manage and maintain lifecycle documentation for validated systems.
• Author protocols for commissioning and qualification activities on client automation/IT-OT projects.
• Ensure all work adheres to client quality policies, GxP requirements, and applicable SOPs, as well as RoviSys internal quality standards.
• Apply good engineering practice (GEP) principles as guidance throughout validation and commissioning work.
• Comply with all client site and RoviSys Safety, Health & Environmental (SHE) requirements; never place yourself or others at risk, and report accidents, near misses, or hazards promptly.
• Observe client site security protocols at all times and report suspicious activity, objects, or damaged security mechanisms to site security immediately.
• Embody RoviSys's continuous improvement culture, applying Lean tools and practices to drive efficiency in validation and project delivery.

Qualifications

• Diploma or B.S. in Computer Science, Chemical Engineering, Electrical Engineering, or equivalent, with relevant work experience/training.
• Experience with IT/Automation system support in a biotech/pharmaceutical manufacturing GMP environment is a plus.
• Familiarity with CSV activities.
• Strong team player able to thrive in a results-oriented, client-facing environment.
• Self-driven, with strong verbal and written communication skills and the ability to collaborate effectively with colleagues and client stakeholders across sites.
• Familiar with AVEVA PI, IT systems or any MES is a plus.