CQV Engineer
2 months ago
About the Role:
Evolve Scientific is seeking a highly skilled CQV Engineer to join our team for a 6-month period. This engineer will be based in the northern suburbs of Melbourne and will be employed by one of our largest pharmaceutical clients. The successful candidate will work closely with the process engineering team to manage ancillary equipment supporting a new syringe filling line at our client's site.
Main Responsibilities:
- Supporting and delivering project objectives, controlling scope changes to meet budget and schedule, functionality according to URSs, Equipment TRSs, GMP, safety, and environmental requirements during all phases of the project.
- 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, and Driving value engineering initiatives.
Requirements:
- Tertiary qualifications in engineering or science.
- 4+ years of engineering or project management experience required.
- 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.
- 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.
Evolve Scientific is an equal opportunities employer and welcomes applications from all qualified candidates. Please submit your application, including a cover letter and detailed resume in WORD format, to be considered for this exciting opportunity.", "requirements": "
- Tertiary qualifications in engineering or science.
- 4+ years of engineering or project management experience required.
- 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.
- 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.