Project Engineer/ Cell Engineer

The Project Engineer / Cell Engineer will provide engineering support in developing new or improving existing equipment and/or process related activities. Define or assist in defining process equipment requirements and specifications based on process and safety requirements and customer needs.

Responsibilities:

· Perform project management tasks for small to medium scale projects involving either new or existing equipment.

· Assist in determining the budget to support requirements.

· Evaluate or assist in evaluating technology necessary to support requirements.

· Propose options to Management/Customer/Stakeholders.

· Provide technical support for projects.

· Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes, and procedures.

· Assist in negotiation with equipment suppliers.

· Utilize necessary project tools, i.e., URS, Microsoft Project, etc. to manage projects successfully.

· Develop the necessary equipment, process, and product knowledge to be recognised as a local expert.

· Measure/evaluate equipment efficiencies, downtime and assist in the development of maintenance requirements.

· Propose and implement improvement projects that improve compliance, improve efficiencies, yields or throughputs.

· Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes.

· Actively interfacing with cross-functional team members, always practicing good teamwork in support of day-to-day operating requirements.

· Ensure effective closure on quality system documents (Audit Action, NCR's, CAPA's, Maps, etc.)

· Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.

Education and Experience Required for Role

· Hold a relevant degree or equivalent qualification in production, manufacturing, or mechanical engineering (essential).

· 4 years' experience in relevant engineering role (desirable).

· Prior experience in a GMP or medical device manufacturing environment (desirable).

· Prior experience in equipment and process validation activities (desirable).

· Process development experience (desirable).

· Familiar with ISO safety standards (essential).

· Previous experience in the use of 'black belt' statistical techniques would be a distinct advantage, as would familiarity with equipment validation in an FDA environment (desirable).

· Have statistical process control and capability analysis using ANOVA and DOE techniques (desirable).

· Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement (essential).

Other Skills and Attributes

· Develop good working relationships across the business.

· Ability to motivate and lead - team orientated.

· Ability to work on own initiative.

· Good project management and communication skills.

If you are interested in having a confidential discussion regarding this opportunity, please reach out to Sarah Walsh on sarah.walsh@orioneng.com for further details.

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