CSV Engineer Delta V (Pharma/Biotech)

The position will require knowledge of the DeltaV programming for the purposes of generating CSV Lifecycle documents for DeltaV processes – VP, Protocols (generation and post-execution review, and Summary Reports). Responsibilities: • Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. • Responsible for preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols. • Perform troubleshooting during test execution. • Responsible for execution of thermal mapping activities. • Write execution related deviations and change requests. • Any other task as assigned by Supervisor/Manager. About You: • Diploma/Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls. • Min. 3 years of experience in CSV preferably in a biotech facility. • Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP) • Familiar with Health Authorities standards (e.g., FDA CFR and EU) • Knowledge of thermal mapping validation and usage of data logger is a plus. • Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams • Must be team player, curious with strong analytical and organizational skills Contract Duration: 6 months