Your new company
Client is an expert in automation and digital systems for pharmaceutical and biotech manufacturing, seeking to hire a yearly contract renewable CSV Engineer.
- Duration: Yearly Contract
- Salary: open for negotiation
Your new role
We are seeking an experienced CSV Engineer with experience in DeltaV, you will play a critical role in leading and executing the DeltaV Computer System Validation (CSV) lifecycle, including validation planning, risk assessments, requirements and design reviews, traceability management, IQ/OQ/PQ execution, regression testing, and final validation reporting.
- Prepare, review, and maintain validation documentation such as User Requirement Specifications (URS), Functional and Design Specifications (FS/DS), risk assessments, traceability matrices, test protocols, deviation records, and validation summary reports.
- Perform qualification of DeltaV infrastructure and hardware components, including ProfessionalPLUS workstations, Application and Operator Stations, M-Series, S-Series, and PK Controllers, CIOCs, I/O subsystems, network architecture, servers, and virtualized platforms.
- Validate DeltaV application software and configurations, including Control Modules, Equipment Modules, Unit Modules, batch recipes, phases, alarms, interlocks, graphics, system interfaces, and security configurations.
- Support design reviews, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, operational readiness, system turnover, and implementation of approved changes.
- Verify compliance and data integrity controls, including audit trails, user access management, role-based security, electronic signatures, backup and recovery processes, and system time synchronization.
- Support cybersecurity compliance and system-hardening initiatives within validated DeltaV environments.
- Participate in the validation and verification of integrations with MES, OSI PI/AVEVA PI Historian, and other manufacturing and enterprise systems, where applicable.
- Manage deviations, change controls, test exceptions, vendor documentation, and validation deliverables through successful closure.
- Collaborate closely with Automation, CQV, Quality, Manufacturing, IT/OT, Engineering, and system integration teams to ensure project and regulatory requirements are met.
What you'll need to succeed
- Bachelor's degree in Engineering, Automation, Instrumentation, Computer Science, Pharmaceutical Technology, or a related technical field.
- Minimum 5 years of hands-on DeltaV Computer System Validation (CSV) experience within pharmaceutical, biotechnology, or other GxP-regulated manufacturing environments.
What you'll get in return
This is an exciting opportunity to contribute to large scale pharmaceutical projects.
What you need to do now
If you're interested in this role, click apply now to forward an up-to-date copy of your CV, or call Rachel at Hays on +65 6027 1923 or email [Confidential Information] for a confidential discussion.
Referrals are welcome.
Registration ID No. R24121588| EA License number: 07C3924 | Company Registration No. 200609504D
