CQV Engineer

About the Role:

This CQV Engineer position is an exciting opportunity to join Evolve Scientific's team as a Pharmaceutical Project Specialist. Based in the northern suburbs of Melbourne, you will be employed for a period of 6 months within one of our largest pharmaceutical clients. As a key member of the process engineering team, you will be responsible for managing ancillary equipment supporting a new syringe filling line to be delivered at our client's site.

Main Responsibilities:

• Supporting and delivering 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.

Requirements:

• Tertiary qualifications in engineering or science.
• 4+ 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.
• 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.

Additional Information:

Evolve Scientific is a leading provider of engineering staffing solutions. With over 90 years' combined experience, we pride ourselves on delivering exceptional service to our clients and candidates. We offer a range of benefits and support to our contractors, including visa and work permit assistance, market-leading benefits packages, and accommodation.