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IrishJobs
Validation EngineerIrishJobsCork, Cork, Ireland
IrishJobs

Validation Engineer

IrishJobs
  • IE
    Cork, Cork, Ireland
  • IE
    Cork, Cork, Ireland

À propos

Objectives To own and support validation activities in a Medical Device regulated environment. Responsibilities Own and support validation activities in a Medical Device regulated environment. Responsible for assigned Process / Equipment / Facility / Utility / Software and Computer System Validation as assigned. Generate Validation Plans, Protocols and Reports in support of assigned validation activity. Resolution of Problems encountered during validation. Ensure Consistency in validation/qualification approach across systems and projects. Provide guidance and direction in the preparation and execution of validation activities Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance. Maintain Validation system including conducting Periodic Reviews. Participate in change control processes for manufacturing Process / Equipment / Facility / Utility / Software and Computer System modifications. Quality: Assure ongoing compliance with quality and industry regulatory requirements. Health & Safety: Ensure compliance with Health & Safety Legislation and Regulations. Measurements Timely and accurate completion of Validations. Compliance with regulatory Standards and requirements. Personnel Specification Qualifications and Experience: QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering. Experience in working within a Medical Device Manufacturing / Pharmaceutical Environment. Minimum of 1 year Quality Assurance / Regulatory affairs experience. Experience of supporting or completing Process / Equipment / Facility / Utility / Software / Computer System Validation. Experience in statistical Analysis / DOE and DMAIC methods. Experience in using the GAMP 5 approach is preferable but not essential. Core Competencies: Technically Competent. Sound understanding and utilization of Problem Solving Techniques. Proficient in the use of MS Word, Power-point and Excel. Ability to respond to common inquiries or complaints from internal customers and regulatory agencies. Ability to write standard operating procedures, training documents, and regulatory responses. #LI-KO1 #plus Skills: Validation Equipment GAMP

TLNT1_IJ

  • Cork, Cork, Ireland

Compétences linguistiques

  • English
Avis aux utilisateurs

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