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SalaryExcellent opportunity for an experienced Senior Computer System Validation Specialist to join a world leading manufacturing business on a very exciting project!
- 6 Months Contract position (possible extension)
- World leading manufacturing business
- Based in Northern Suburbs of Metro Melbourne
This is an excellent opportunity for an experienced Senior Computer System Validation Specialist to join a leading manufacturing business, working on a highly interesting project. The position will be based in the Northern part of the Melbourne and is a 6-month full time contract role.
Job Description:
The Senior Computer System Validation Specialist will ensure all computerized systems used to support GMP operations are appropriately validated and controlled.
Main Responsibilities
- Collaborate with Site and Global validation team to build alignment of ES validation expectations.
- Collaborate with ES Project Execution team to ensure the oversite of CSV activities associated with the project.
- Provide support of change management procedures and processes in collaboration with Quality.
- Support of the ES validation strategy/validation master plan in alignment with the Quality Organization.
- Accountable for the preparation, delivery, and execution of CSV owned validation protocols.
- Responsible for the System Development Lifecycle and validated the state of ES owned platforms.
- Ownership of investigations, CAPAs and quality and compliance KPIs.
- Responsible for Data Integrity Assessment execution.
- Responsible for the Document Periodic Review process
Experience and Qualifications:
- Minimum a Bachelor's in Engineering, Computer Sciences or similar field
- 4-5 years experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, 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 computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5. Capabilities
- Working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized systems
- Understanding of business and manufacturing logistics and processes.
- Proven ability to work within and contribute to a high performing team.
- Self-motivated, demonstrates initiative, propensity to drive change
- Detail oriented, with strong written and verbal communication skills.
- Strong understanding of US, European, and or Australian applicable regulations
Must Haves:
As these activities are to address audit findings relating to data integrity, the resource must have a good understanding of cGxP and ALCOA principles.
Furthermore as the findings are against legacy systems this individual must be able to independently access knowledge and experience in relation to these systems such as MOD 300 and v7.0 PCS 7 systems. There are a number of tasks which require various Subject Matter Experts to come together to close tasks so some project management skills would be highly desirable.
Design & Build specializes in recruitment for the Construction, Manufacturing, Engineering & Property industries on a national basis. Design & Build prides itself on only hiring recruitment specialists, finding the right people for the right jobs and doing the right thing by both job seekers and employers alike.
For any questions relating to this role please contact Chris on 0412 747 198 / cmccutcheon@designandbuild.com.au or click apply. Your application will be treated as strictly confidential.
Thanks for your consideration.
