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PROJECT VALIDATION SPECIALIST - ENGINEERING SYSTEMS

Melbourne, $100,000+ (Sponsorship/Relocation assistance available)

CSL Limited is a company that fosters a work culture emphasising Superior Performance, Innovation, Integrity, Collaboration and Customer Focus with a commitment to support, train and grow its people. As a genuine leader in the biopharmaceutical industry, CSL is a multinational ASX Listed Company that is actively growing its Australian based manufacturing operations to support global growth. CSL develops, manufactures and markets products to treat and prevent serious human medical conditions and is globally one of the largest manufacturers of plasma-derived therapies.

The Role

As part of our continued growth we are seeking a Project Engineer to provide front line technical guidance to the Engineering Project Managers in the Selection, Specification and Design aspects of Capital equipment throughout the IQ/OQ phase. We are particularly focused on people with strong Management Systems knowledge who can also bring homogeneity and best practice to the supporting documentation and ensure a smooth transition of commissioned equipment to the Validation team (for PQ).  

You will be responsible for:

  • Working closely with Engineering Department to update Quality Systems/Documentation within the Project Management group
  • Serves as liaison with other CSL sites to assure harmonization with global practices and capitalising on the existing knowledge base within our sister sites
  • Coordinate technical feedback and URS requirements with Operations, Quality and Validation stakeholders
  • Coordinate and enhance equipment transition process to minimise rework
  • Actively seek out and drive best practice for the Management systems that support the Engineering project groups
  • Actively Improve Process, cGMP and Characterisation metrics through the facility
  • Directly lead and inspire a team of qualified and experienced Pharmaceutical Engineers
  • Keep across any regulatory updates that might impact the selection and design of equipment across site (e.g. 21CFR – 11, PIC/S)

To be successful in this role you will have a tertiary degree in Engineering or Science with a minimum of 8 years’ experience within Pharmaceutical Engineering. You will have significant knowledge around cGMP. Experience with new facility qualification and start-up commercialization is highly desired. You will have a proactive leadership style and significant project management experience. You will also have strong stakeholder management and problems solving abilities and be an effective influencer.

Applications must address the selection criteria above and include a current CV and covering letter.

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation process.

 



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