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.

Safety, Health & Environment

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.

Continuous Improvement

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.

CSV Automation Engineer