About the Role:

This CQV Engineer will be employed by Evolve Scientific for a period of 6 months to support a pharmaceutical client in the northern suburbs of Melbourne. The engineer will work alongside the process engineering team to manage ancillary equipment supporting a new syringe filling line.

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.
• 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 services, with over 90 years' combined experience in the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide.