Project Engineer

As part of the engineering operations team, you will work on engineering projects leading to the introduction of new equipment or major equipment improvements to support existing product ranges. This role is critical in ensuring products can be manufactured to the highest standard possible, in line with volume forecasts whilst reducing operational costs. Consideration of current and future product and operational requirements at an early stage will ensure long-term value is achieved from the capital equipment.

The primary objective of this role is to drive execution of the project engineering activities in line with the company strategy, ensuring consistent engineering practices and processes at the strategic and manufacturing facilities in accordance with delivering effective plant metrics centered on Safety, Quality, Cost, and Delivery expectations.

Duties and Responsibilities

1. Lead Process development & New equipment integration (Install through to manufacturing handover)
2. Lead & Support FAT, SAT, IQ, OQ, PQ validation
3. Lead design reviews with machinery vendors
4. Update and maintain change control systems and associated documentation
5. Focused support for production output to maintain attainment delivery
6. Execute Engineering tasks associated with new process introduction
7. Identify and deliver competitive COGs associated with Lean process creation
8. Identify opportunities during process development to improve process capability, machine performance, and uptime
9. Adhere to legal, corporate, and site legislation, and procedures
10. Compliance with GMP requirements and uphold these standards
11. Compliance with EHS requirements and uphold these standards
12. Seek and deliver CI opportunities through project development

Education /Qualifications

1. Degree, or equivalent in an Engineering Discipline
2. Time served engineering background
3. Six Sigma Green Belt, or demonstrates a similar approach to problem solving
4. PC Skills including SAP, Word, Excel, PowerPoint, MS Project, CAD
5. Trained in IQ, OQ, PQ validation principles

Requirements:

1. Relevant work experience as a Project Engineer
2. Experience of working in a regulated environment
3. Demonstrated expertise in problem solving
4. Must have in-depth working knowledge of all processes and equipment within focus factory
5. Understand the implications and requirements of external regulations, particularly GAMP5, FDA & MHRA, EHS, and manufacturing legislation
6. Demonstrated project and time management skills, including a track record of creating plans and meeting deadlines
7. Proven ability to balance multiple, competing priorities
8. Demonstrated interpersonal skills and a good team player, proactive and flexible approach
9. Time served apprentice trained (desirable)
10. Medical device experience (desirable)

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.