Job Description

Responsibilities:

Lead CSV activities for Computer Systems e.g. DeltaV, BAS, PLCs, MES and related mini-projects 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. Work largely requires use of valgenesis software to create validation documents and electronic test case execution Work with SME to generate test cases and CSV documents. Provide guidance on test case execution and exception handling. Support SME on documentation matters and ensure documents are completed in time. Any other task as assigned by Supervisor/Manager.

About You:

Bachelor of Science/Engineering or higher in a scientific or engineering discipline Proven senior-level experience in biotech validation work A track record of independently planning, executing, and closing CSV activities Able to work independently with not much supervision Strong autonomy in generating lifecycle documentations, test plan/cases, managing exceptions, and completing deliverables. 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 Strong ownership
Job Type: Contract
Contract length: 9 months

Pay: $5,000.00 - $8,500.00 per month

Benefits:

Health insurance
Work Location: In person