This position is responsible for the validation of enterprise resource planning systems, automated equipment and/or control systems. Familiarity in DCS (Distributed Control System), PLC/SCADA and OSI PI is a plus. In this role, the engineer has to work in accordance with the company’s policies and procedures to ensure validation is performed in accordance with quality requirements and regulations.
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.
- Work with QA and stakeholders to develop the CSV strategy
- Responsible for providing CSV documents and protocols, performing execution for automated equipment and/or control systems, and closure of executed protocols.
- Responsible for test case execution, deviation handling and drafting of system SOPs.
- Any other task as assigned by Supervisor/Manager.
About You:
- Bachelor Degree in a scientific or related engineering discipline with at least 5 years' experiences in CSV QA validation.
- Good understanding of DeltaV coding and configuration in order to support CSV protocol generation and review for DeltaV processes.
- Knowledge of validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Familiar with Health Authorities standards (e.g. FDA CFR and EU)
- Must be team player, curious with strong analytical and organizational skills
Job Type: Contract
Contract length: 9 months
Pay: $5,500.00 - $9,500.00 per month
Experience:
- DCS (Distributed Control System): 5 years (Preferred)
- Computer System Validation Lifecycle: 5 years (Preferred)