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Regulated Operations Engineer

https://www.csiro.au/ Logo

CSIRO

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Location:
Australia, Melbourne

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Category:
Manufacturing

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Contract Type:
Employment contract

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Salary:

131113.00 - 153639.00 AUD / Year

Job Description:

Join CSIRO as a Regulated Operations Engineer and contribute to Australia's biomedical manufacturing capability. In this role, you'll support the operation of a GMP-compliant manufacturing and QC laboratory facility producing clinical trial materials for Phase 1 and 2 studies. You'll work closely with multidisciplinary teams to provide engineering support across equipment qualification, process validation, and facility operations, ensuring compliance with regulatory standards and internal quality systems. This is a hands-on, collaborative role suited to engineers with experience in regulated environments who are passionate about continuous improvement and technical excellence in support of national health priorities.

Job Responsibility:

  • Support troubleshooting and resolution of facility, plant and equipment issues impacting production
  • Establish project specifications by studying facility design, customer requirements, performance standards and completing technical studies
  • Author and execute commissioning or validation protocols (IQ/OQ/PQ) for equipment, utilities, and systems as required
  • Execute requalification activities and maintain validation lifecycle documentation in compliance with GMP and regulatory expectations
  • Assist in the design, installation, and commissioning of new equipment and facility upgrades
  • Provide technical support in facility boundaries during tech transfers and scale-up activities
  • Support GMP manufacturing and QC operations for clinical trial material production
  • Lead equipment qualification, process validation, and continuous improvement initiatives
  • Collaborate with cross-functional teams to ensure regulatory compliance and technical excellence

Requirements:

  • Bachelor's degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent relevant work experience
  • Demonstrable experience (minimum 5 years) with operation, validation and/or management of GMP-regulated pharmaceutical manufacturing facilities, plants and equipment
  • Experience with facility systems (HVAC, clean utilities, EMS etc) and equipment qualification
  • Demonstrated ability to undertake original, creative and innovative research by generating and pursuing novel ideas and solutions to scientific research problems
  • Experience of providing technical support to the design, development, and implementation of new projects
  • Strong understanding of GMP, validation principles, and regulatory expectations (TGA, FDA etc)
What we offer:
  • 15.4% superannuation
  • Flexible work arrangements
  • Range of leave entitlements
  • Career development opportunities

Additional Information:

Job Posted:
October 07, 2025

Expiration:
November 03, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:
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