Validation Quality Engineer
Leading and expanding Medical Device Multinational in Cork, have a requirement for a dynamic and experienced Validation Quality Engineer to join their expanding quality team.
A little about the Company..
They have invested heavily into this site with further plans to expand with a lot of NPI's currently being introduced. It is a very exciting time to be joining this Company. My client has a very inclusive, positive and ''down to earth'' work culture that values ongoing collaboration and teamwork. It genuinely is a lovely place to work, with a ''family feel'' to the Company but with the resources and support of a multinational.
A little about the role…
This is a very interesting ''Hybrid'' role - You will be involved in various cleaning and validation projects, working closely with the various technical and operations teams, supporting the validation, change management and in process monitoring. You will be involved in the validation of equipment and you will also ''own'' the cleaning project - new processes and equipment are being introduced! You will get excellent exposure internally & externally - locally and globally as you will be working closely with their sister site to introduce these processes onsite in Cork
- Review and approval of validation documentation related to all other new equipment.
- Review and execution of process validations related to special processes ensuring compliance to all internal requirements as well as FDA and ISO regulations.
- Identify and implement cost saving initiatives related to the validation process.
- Develop and implement comprehensive test plans as well as test methods to ensure that the processes are robust
- Quality Engineering Operations point of contact for production when risk assessing or troubleshooting new and existing issues (design, materials or equipment, and provide creative, timely, and cost-effective solutions.)
- Represent Quality Engineering Operations on validation related projects
- Support Quality for non-conformities and CAPA
- Support QA and RA groups during audits- especially Critical In Process and Final Cleaning processes.
- Review, approval and/or execution of the Change Control process when required.
- Minimum Level 7 qualification in a related engineering degree.
- Minimum of 5 years experience in a similar Engineering position within the Medical Device Industry preferred, may also consider Pharma Industry.
- Looking for someone with strong validation experience particularly around cleaning processes -final cleaning in process cleaning, execution of ISO 19227 preferred.
- Experienced in validating equipment but also knowing whats required in terms of processes and standards associated with this.
- Excellent communication and interpersonal skills re any delays with projects - proven ability to develop good working cross functional relationships
- Down to earth, hardworking and dynamic attitude with excellent problem solving and technical ability.
Click Apply now to review the full details and job spec for this amazing opportunity. I will guide you through the whole process!
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