Reporting to the Senior Project Lead, the Equipment / Project Engineer will be a key member of a project team, working together to develop and implement highly automated, high speed production equipment for the manufacture of regulated devices.
The Equipment / Project Engineer will contribute throughout the Automated Equipment Life Cycle - through development phase / specification phase / design phase / construction phase & qualification phase.
The Equipment / Project Engineer will be work closely with selected vendors on the design, build, debug and installation of specified pieces of equipment, including significant contribution to the URS, FAT, SAT, IQOQ & OQPQ in collaboration with the validation engineer, process engineer and project technician.
DUTIES AND RESPONSIBILITIES:
- Participate in a cross functional project team to establish to support the development and introduction of the new automated production equipment.
- Contribute to the specification of the equipment. Work in conjunction with the Process Engineer to develop appropriate URS documents for each larger element of the line.
- Support the validation engineer in the development of the Functional Specifications, Trace Matrix.
- Drive design reviews and build inspections with Equipment vendors.
- Drive regular status review meetings with vendors.
- Develop and maintain project timeline for various pieces of equipment.
- Set-up vendor FAT and support the validation engineer in preparing and executing FAT / SAT protocols.
- There will be a requirement to travel to Equipment Manufacturer in Europe for short trips as part of this project (for design reviews/ build inspections / FAT execution).
- Lead the installation phase of the equipment.
- Support the validation engineer in preparing and executing Equipment IQ & OQ Protocols and the preparation of associated reports.
- Work in conjunction with the Process/Manufacturing Engineer to prepare for and execute Process OQ/PQ protocols.
- Any other responsibility as set out by Supervisor/ Manager.
- A qualification in appropriate Engineering discipline and at least 6 years relevant experience in a regulated environment.
- Previous Experience in the development / validation / & commissioning of automated manufacturing equipment is essential.
- Working knowledge of PLCs and assembly automation control systems a distinct advantage.
- Working knowledge of vision systems an advantage.
- Working knowledge of moulding equipment an advantage.
- Strong vendor management experience required.
- Good regulatory knowledge.
- Good verbal and written communication skills, including the ability to conduct verbal presentations.
- Demonstrated success working in a team environment.
- Ability to work under pressure to meet scheduled deadlines.
- Proven technical protocol and report writing skills.