Description
Quality Validation Engineer responsible for providing guidance on all aspects of quality, validation and quality engineering within a cross functional team thus ensuring customer satisfaction and reduction of scrap with a leading biotech company based in South Dublin.Job Title: Quality Validation Engineer
Location: South Dublin
Salary: €40,000 - €50,000
The Quality/Validation Engineer will be responsible for:
* Support to Operations through the product life cycle / process for defined product portfolios
* Management of process deviations, non conformances, reworks, CAPA, Design Changes, complaints, scrap and change requests for product group
* Lead Validation activities for designated product groups
* Conduct process and GMP audits and ensure area compliance
* Liaise with regulatory department to ensure product supply is maintained and all quality aspects are met
* Champion QA and continuous improvement initiatives
Education and Experience:
* Graduate in a science, engineering or related background
* 3-5 years in a QA Engineering / QE Experience, working within a recognised quality system within IVD, Medical Device or Pharma industry
* 2-3 years validation experience in equipment/process/software is highly desirable.
* A working knowledge of regulatory requirements
* A technical background or knowledge of IVD products or Medical devices would be advantageous
* Awareness of statistical techniques and validation
* Experience of internal, third party regulatory & external customer audits
* A high degree of computer literacy
The Company/Culture:
* A global Biotech with products in over 75 countries
* Friendly working environment, great team work.
* Family orientated company with multiple employee well-being initiatives in place
* Superb long term career opportunities.
Skills and Behaviours:
* The ideal candidate should demonstrate a logical and planned approach to all tasks
* Excellent written, oral and communication skills
* Be a team player and have high personal confidence, ability to liaise with other business divisions
* The ability to work in a multi-disciplinary team environment
* Ability to work on their own initiative
* Be customer-focused
* Have a high attention to detail
* Be flexible and willing to carry out overtime as necessary when required
* Be conscious of Health & Safety requirements at all times
If you are interested in hearing more about this fantastic opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.