Operational Readiness Lead M2U

January 6th, 2024
Broadmeadows, Victoria, Australia
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About the company
Evolve Scientific are currently searching for a highly skilled Operational Readiness Engineer (Lead) join with one of our largest clients, a Global leader in the Pharmaceutical Industry. This client is looking to bring aboard this engineer for a 12-month contract with a strong probability to extend into a permanent position. Based in the Northern suburbs, this will be an onsite position.

About the role:
To conduct and coordinate engineering activities for the keystone AlbuRx Capacity Expansion Project (BACE II) and ensure effective handover of the project to routine operations beginning of 2026.
The focus of this role will be to act as the Operational Readiness representative for the Maintenance and Utilities (M2U) department and conduct engineering and maintenance services to support project delivery of the production areas (Bulk Process and Fill/Finish).

The Operational Readiness Lead will:

  • Act as Engineering Plant owner during BACE II project throughout key stages of Design, Procurement, FAT, Installation, Commissioning, SAT, Qualification and Handover.
  • Develop and provide equipment reliability and process engineering expertise for the BACE II project including FMEA, creation of maintenance plans and spare parts assessments.
  • Ensure that all engineering tasks related to Operational Readiness are completed in a timely manner to allow smooth transition through completion of qualification, validation, PPQ batches and onward to routine production.
  • Investigate, develop, and implement solutions to engineering problems related to new manufacturing equipment and systems.
  • Develop and apply engineering standards and procedures and provide advice on issues within the engineering field.
  • Liaise with external Vendors/Consultants and internal Engineering, Production and Quality colleagues to achieve BACE II project objectives.
Key responsibilities include:
  • Reviewing design specification documents (P&IDs, flow paths, specifications)
  • Reviewing differences between existing BACE I and new BACE II plants
  • Reviewing 3D models
  • Leading Device (Instrumentation) and Criticality Assessments
  • Providing input for maintenance procedures (i.e. access to equipment for job tasks)
  • Liaising with the data entry team to coordinate asset creation in SAP.
  • Leading maintenance FMEA
  • Liaising with maintenance teams and planning departments to develop Preventative Maintenance plans (PMs).
  • Developing mechanical and E&I spare part requirements.
  • Reviewing and participating in FAT’s.
  • Participating in safety assessments (e.g. HAZOP, LOPA)
    • Support installation, commissioning, and qualification activities to facilitate knowledge transfer from the project to operations.
  • Receiving the final project handover of processing plant
  • Leading the transfer of knowledge to the M2U team.
  • Attending to TGA/FDA audits
To be considered for the role, the ideal candidates must have:
  • A minimum of 3 years’ experience in Maintenance or Process Engineering.
  • Experience/exposure to tier 1 Capital Projects or Pharmaceuticals manufacturing within Australia or another highly regulated market (cGxP systems).
To be successful for the role, the ideal candidates will have:
  • Maintenance/Process Engineering experience specifically with highly automated pharmaceutical equipment (Siemens PC7 desirable).
  • Pharmaceutical Bulk Processing or Fill/Finish experience
  • Project Engineering or Operational Readiness experience
  • Direction of maintenance personnel working on the plant
  • Management of a computerised maintenance management system
  • Operational experience in the requirements of the code of Good Manufacturing Practice [cGMP] in a pharmaceutical environment.
How to Apply:
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 only accepted from Australian / NZ residents with valid Australian work rights or temporary residents on work visas e.g., Working Holiday Visa.

Need more information:

Please call Max on 0416 877 631 or alternatively Deborah on 0451 056 185.

How to Register with Evolve:

For upcoming positions please click on the "Apply Now” button. By applying to any of our roles you will also be registered for future positions unless you request not to be.

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.

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