Senior Computer System Validation Specialist

About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.

About the opportunity
The Senior Computer System Validation Specialists will be responsible for authorising and executing deliverables along with liaising with stakeholders and ensuring documents meet all global stands.

Duties

• Authoring and executing CSV deliverables, writing plans, reports, specifications and other documentation
• Liaising with subject matter experts
• Ensuring coordination of documentation occurs and that all documentation is written in a timely manner and that deadlines are met
• Ensuring documents are written to global standards
• Project management tasks

Skills and Experience

• Bachelor’s degree in Engineering, Computer Sciences
• 4-5 years experience with CSV methodologies in operation IT, OT, and Automation positions
• Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for life-sciences and related best practices for compliance and risk based approach.
• Experience with Automation and MES projects and computer validation methodologies.
• Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ)
• CSV inspection readiness preparations and/or directly support regulatory agency inspections.
• Exposure to Execution Systems technologies, including automated data collection, historian applications (OSI PI), SCADA, automated decision control, workflow, database applications, and interfaces to ERP, LIMS, etc.
• Understanding of industry standards related to computerised systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
• Strong project management skills
• Siemens PCS7 (Process Control Systems 7)

Culture
Although a large, global company, they are able to provide a family-like culture and pride itself in improving the lives of others.

Why this opportunity is right for you
This is a Full-time 12 month contract opportunity to work within an excellent team environment. Majority will be working on-site in the Northern suburbs of Melbourne.

How to Apply
Click apply or contact Jo Turner, Senior Specialist Manager on 03 9938 7100 for a confidential discussion.