CSV Engineer Delta V (Pharma/Biotech)

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

Additional Information

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).

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at NUSANTARA PRIME CONSULTING PTE. LTD.? Share your experience