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Validation Engineer

vor 1 Monat

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Role: Validation Engineer

Location: Carrick on Shannon, Leitrim

Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working

Company:
Work with the largest employer in Leitrim specializing in making Catheters in-house. The company has cleanrooms dedicated to customers and offers about 100 promotions per year, with projects involved, individual plans, goal setting, and leadership training.

Responsibilities:

  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845. Generation of Product Technical Files & associated studies.
  • Completion of Validation Programme – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures.
  • Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
  • Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
  • Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
  • Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/suggestions for improvement and by reporting accidents, dangerous occurrences, near misses/illnesses, good catches, and environmental incidents in a timely manner.

Qualifications:

  • Required: Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline.
  • 1+ years’ experience in a Quality role in Medical Device/Pharmaceutical Environment.
  • An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.

Does this sound like your next career move? For more info, forward your application or contact me on 087 0612325 or thomas.gallagher@lifescience.ie.

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