Computer System Validation Specialist
2 days ago
**As a computer systems validation specialist you will work as part of a multidiscipline team, supporting the design, construction, commissioning and qualification of new and modified pharmaceutical and life science facilities, equipment and processes.**
**Responsibilities**:
- Primary focused on Emerson DeltaV, Siemens PLC, MES, LIMS and Data Historian systems
- Develop various test specifications which includes functional testing, system integration testing, performance testing and compliance testing
- Perform validation activities in accordance to international (GxP) and national regulations and standards
- Develop, execute, review and approve CSV documents and reports and coordinate CSV work execution with client and various contractors.
- Generate Validation Summary Reports and Standard Operating Procedures (SOPs)
- Conduct Risk Assessments
- Ensuring full compliance to regulatory, quality and best practice standards
**Requirements**:
- Degree in Electrical/Chemical/Mechanical Engineering or Computer Science or equivalent
- Minimum 3 - 5 years of experience working in a GMP environment
- Familiar with compliance requirements, e.g. FDA, EMA, GxP, GAMP 5, 21 CFR Part 11, etc.
- Experience in implementing any of the following systems: DeltaV DCS, PLC/SCADA, Electronic Batch Records, MES, ERP and LIMS
- **Must be comfortable with Contract basis role
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