Benefits Be part of a supportive and stable working environment Working within a global team
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.
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 position with a good understanding of pharmaceuticals, biotechnology, chemistry, and food industries.
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) and
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)
Technical knowledge highly desirable
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 working on site but is a Monday to Friday role only.
How to Apply Click apply or contact Jo Turner, Senior Specialist Manager on 03 9938 7100 for a confidential discussion.
BenefitsDynamic and fast-paced work environmentOpportunity for professional growthHybrid working environment.8 to 9 month project with potential to extend. About the companyA global company specialising in diagnostic equipment within the medical devices industry, renowned for their innovative cult...