Graduate Validation Engineer

4 days ago


Fermoy, Cork, Ireland TN Ireland Full time

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REPORTING TO: Lead Quality Engineer – Validation / NPI

DIRECT REPORTS: N/A

OBJECTIVES OF POSITION:

  • To formulate and execute validation plans for medical devices.

RESPONSIBILITIES:

  • Support validation activities in a Medical Device regulated environment.
  • Support Process Validation Execution in Fermoy.
  • Support Software Validation Execution in Fermoy.
  • Assist with resolution of Problems encountered during validation.
  • Become fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
  • Participate in change control processes for manufacturing process and facility 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 SPECIFICATIONS:

ESSENTIAL:

  • Minimum Level 7 Degree/ Diploma (Preferably in a Science, Electronics, Mechanical or Industrial Engineering).
  • Sound understanding and utilization of Problem Solving Techniques.
  • Proficient in the use of MS Word, Power-point and Excel.
  • Ability to write standard operating procedures, training documents, and regulatory responses.
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