AddressEvolve Scientific are currently searching for a highly skilled Automation Engineer to join with one of our largest clients, a Global leader in the Pharmaceutical Industry. Our client is looking to bring aboard this professional for a 6-month contract, with a likelihood of extension.
About the role:
Based in an inner-northern suburb of Melbourne, this Automation Engineer will be responsible for ensuring that all computerized systems used to support GMP operations are appropriately validated and controlled. This Automation Engineer will be involved in the global integrity programme for corrective and preventative actions within our client’s PLC systems.
Key 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 Organisations.
- Responsible for the System Development Life-cycle 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
To be considered for the role, the ideal candidates must have:
- At minimum, a bachelors in engineering, Computer Sciences, IT or similar field
- A working knowledge of software development life-cycle (SDLC) model and validation practices of various computerised systems
- An Understanding of business and manufacturing logistics and processes
- A proven ability to work within and contribute to a high performing team.
- A self-motivated, demonstrates initiative, propensity to drive change.
- A detail oriented, with strong written and verbal communication skills
- A strong understanding of US, European, and or Australian applicable regulations.
- 4 to 5 years’ experience of 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
Click on the "Apply Now" button with a cover letter addressing the selection criteria above AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
*Note: Applications NOT accepted from those without full working rights in Australia
Need more information:
Please call Max on 0416 877 *** or alternatively Deborah on 0451 056 ***.
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Why Evolve Scientific Recruitment?
Evolve is an award-winning agency specialising in scientific/technical recruitment in: Pharmaceutical, Food, Biotechnology, Chemical, Petrochemical, Environmental, Health Services, Life Sciences, Mining and more.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
