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As part of the engineering operations team, working 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 cost. 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. Whilst ensuring consistent engineering practises, 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
- Lead Process development & New equipment integration (Install through to manufacturing handover)
- Lead & Support FAT, SAT, IQ, OQ, PQ validation
- Lead design review's with machinery vendors.
- Update and maintain change control systems and associated documentation
- Focused support for production output to maintain attainment delivery
- Execute Engineering tasks associated to new process introduction
- Identify and deliver competitive COGs associated to Lean process creation
- Identify opportunities during process development to improve process capability, machine performance and uptime
- Adhere to legal, corporate and site legislation, and procedures
- Compliance with GMP requirements and uphold these standards
- Compliance with EHS requirements and uphold these standards
- Seek and deliver CI opportunities through project development
Education /Qualifications
- Degree, or equivalent in an Engineering Discipline
- Time served engineering background
- Six Sigma Green Belt, or demonstrates a similar approach to problem solving
- PC Skills including SAP, Word, Excel, PowerPoint, MS Project, CAD
- Trained in IQ, OQ, PQ validation principles
Requirements:
- Relevant work experience as a Procect Engineer.
- Experience of working in a regulated environment
- Demonstrated expertise in problem solving.
- Must have in-depth working knowledge of all processes and equipment within focus factory
- Understand the implications and requirements of external regulations, particularly GAMP5, FDA & MHRA, EHS and manufacturing legislation.
- Demonstrated project and time management skills, including a track record of creating plans and meeting deadlines.
- Proven ability to balance multiple, competing priorities
- Demonstrated interpersonal skills and a good team player, proactive and flexible approach.
- Time served apprentice trained (desirable)
- Medical device experience (desirable)
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
