Telephone: 086 8395533
Snr Quality Engineer Process Validation - Contract
Our client, a medical device company in Galway is currently looking to recruit an Snr Quality Engineer Process Validation for their site on a contract basis.
- Within the Quality Engineering Validation Department, focus on execution of process validation activities that exceed the requirements and expectations of patients, physicians, regulatory agencies and the business. The Quality Engineering Validation Department is directly involved in the development of the validation strategies and execution of the validation activities releasing novel processes and products to commercialization.
- You will take a lead role in the planning and the execution of process validation activities for new products, technology transfers and improvement projects.
- You will play a key role in providing Quality input into new product development, process improvements and change control.
- You will support the characterization and risk assessment of manufacturing processes and associated equipment.
- You will work with project team members to establish process controls that ensure the safety and efficacy of the product.
- You will liaise with cross functional team members, developing strong partnering relationships with these groups.
- You will have an expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, validation, technology transfer and commercialization activities.
- You will lead and support root cause driven approaches to problem solving efforts for quality issues.
- You will use and establish analysis techniques and other quality tools to aid decision making.
- We are looking for a person qualified to a Level 8 Third Level Degree in Science, Engineering or related discipline and desirably with 5 -8 years’ relevant experience or 3 -6 years’ relevant experience with a relevant Master’s Degree.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- You are experienced with the ability to be self-directed and to effectively interface with various levels and functions within the organization.
- Ability to recognize, anticipate and innovatively create solutions to issues and problems in a timely manner is desirable.
- Having broad technical expertise and knowledge of interrelated quality function disciplines and a high level of aptitude in QE/QA principles and methodologies is advantageous.
- A good working knowledge of process validation requirements.
- Some experience or background in combination or pharmaceutical products would also be beneficial.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Senior Quality Engineer role in Galway please contact Bimi on 086 8395533 / email@example.com
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