Senior Computer Systems Validation Engineer

April 2nd, 2024
Jacana, Victoria, Australia
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About the company

Evolve Scientific are currently searching for a highly skilled Computer Systems/Automation Engineer for one of our clients in the pharmaceuticals sector.  

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.

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 Organization.
  • 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
To be considered for the role, the ideal candidates must have:
  • At Minimum, a bachelor’s in engineering, Computer Sciences, IT or similar field
  • A working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized 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
To be successful for the role, the ideal candidates will have:
  • 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
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).  
Or, if you have any questions, please contact Deborah Cusmano or Max Monroe on 9040 1630

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.

Submission Form

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