CSV Engineer Delta V (Pharma/Biotech) - Part-Time

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