AddressBased in the northern suburbs of Melbourne, this CQV Engineer will be employed for a period of 6 months within one of Evolve Scientific’s largest pharmaceuticals clients. This engineer will be working alongside the process engineering team and will be responsible for managing ancillary equipment supporting a new syringe filling line to be delivered at our clients’ site.
Main responsibilities:
Supporting and delivering the project objectives, controlling scope changes to meet budget and schedule, functionality according to the URSs, Equipment TRSs, GMP, safety and environmental requirements during all phases of the project (Design, Procurement, Construction, Commissioning and Qualification).
- Supporting the filling line design
- Design Qualification
- GMP Equipment procurement
- Equipment FATs
- Off-site Fabrication and On-site installation of equipment
- FAT (Factory Acceptance Testing)
- SAT (Site Acceptance Testing)
- Commissioning of the Equipment
- Qualification of the Equipment
- Driving value engineering initiatives and maintaining strategic engagement across multiple local and global business groups.
- Tertiary qualifications in engineering, or science.
- 2+ years of engineering or project management experience required.
- A demonstrated ability to work closely with multiple project teams and project managers supporting large and highly complex projects.
- Prior experience in qualification and commissioning of highly regulated equipment.
- This means any experience from dairy, FMCG, pharmaceuticals, medical devices, or other associated biotech experience.
- Computer literacy and experience using Microsoft applications.
- Strong PLC/SAP experience
- An underlying process and engineering systems/services experience gained in the GxP industry
- Experience in troubleshooting, process engineering and ability to understand and implement client requirements.
- Experience with installation, commissioning, and operation of filling equipment, parts washers and autoclaves.
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letterAND 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
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