Job Title: Project Engineer
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This role involves providing engineering support in the development of new or improved equipment and processes. You will define process equipment requirements and specifications, perform project management tasks for small to medium scale projects, assist in determining budgets, evaluate technology, propose options to stakeholders, and provide technical support.
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Duties and Responsibilities:
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1. Provide engineering support in developing new or improving existing equipment and/or process related activities.
2. Define or assist in defining process equipment requirements and specifications based on process requirements, safety requirements, and customer needs.
3. Perform project management tasks for small to medium scale projects involving either new or existing equipment.
4. Assist in determining the budget to support requirements.
5. Evaluate or assist in evaluating technology necessary to support requirements.
6. Propose options to Management/Customer/Stakeholders.
7. Provide technical support for projects.
8. Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes, and procedures.
9. Assist in negotiation with equipment suppliers.
10. Utilize necessary project tools, i.e. URS, Microsoft Project, etc. to manage projects successfully.
11. Develop the necessary equipment, process, and product knowledge to be recognized as a local expert.
12. Measure/evaluate equipment efficiencies, downtime, and assist in the development of maintenance requirements.
13. Propose and implement improvement projects that improve compliance, improve efficiencies, yields, or throughputs.
14. Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes.
15. Actively interfacing with cross-functional team members, always practicing good teamwork in support of day-to-day operating requirements.
16. Ensure effective closure on quality system documents (Audit Action, NCR's, CAPA's, Maps, etc.).
17. Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.
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Requirements:
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* Degree or equivalent qualification in production, manufacturing, or mechanical engineering.
* 4 years' experience in relevant engineering role.
* Prior experience in a GMP or medical device manufacturing environment.
* Prior experience in equipment and process validation activities.
* Process development experience.
* Familiar with ISO safety standards.
* Previous experience in the use of 'black belt' statistical techniques would be a distinct advantage, as would familiarity with equipment validation in a FDA environment.
* Have statistical process control and capability analysis using ANOVA and DOE techniques.
* Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement.
* Develop good working relationships across the business.
* Ability to motivate and lead - must be team orientated.
* Ability to work on own initiative.
* Good project management and communication skills.
* Attention to detail.
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Benefits:
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* Competitive salary and holiday entitlements.
* Flexible hours and remote working options; role dependant.
* Pension Scheme.
* Healthcare Insurance cover.
* Further education financial assistance.
* Access to a personal financial advisor.
* Bike to work scheme.
* Employee engagement and company-wide events.
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About Us:
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We are a leading engineering solutions company specialising in Project Management, Operations & Maintenance, and Commissioning. We operate in various industries including Semi-Conductor, Pharma, Med Device, Datacentre, and Automotive.