- Posted 30 November 2022
- Salary Negotiable
- DisciplineLife Science
- Contact NameSarah Walsh
Orion Group Life Sciences are currently recruiting a Senior Project Engineer on behalf of our Multinational Medical Device client in Limerick for an initial 12-month contract.
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.
· 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 email@example.com for further details.
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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.