Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Clara Burke
email science@hero.ie

Senior Validation Engineer

Job ID: JOB-11557
Senior Validation Engineer

Our client a leading medical device company in Galway is recruiting for a Senior Validation Engineer for their Galway site.

Responsibilities and Duties

  • Generate validation documentation including DV, IQ, OQ, PQ protocols and validation reports, and assist in the execution of protocols.
  • Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances.
  • Maintain consistency on validation/ qualification approach across projects, ensuring validation documentation is fully compliant with site specific policies/ procedures and regulations, good manufacturing practices and industry regulations.
  • Be supportive of, and encouraging of others in the project team, showing flexibility in the delivery of team results.
  • Engaging with cross functional teams to deliver process validation objectives in compliance with regulations and procedures.
  • Responsibility for delivery of project timelines.
  • Ensure all project related issues and deviations are documented and approved.
  • Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances.
  • Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.

Requirements

  • Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
  • High understanding of Compliance, Validation Practices including the system development life cycle & Regulations.
  • Excellent interpersonal, written and verbal communication skills, including ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies etc., in a multi-disciplinary team environment.
  • Ability to work as a team player in a consulting environment.
  • Proficient with MS Word, Excel, Power Point, and management of spreadsheets.

Education & Experience

  • Third level qualification in Science or Engineering.
  • A minimum of 5 years’ experience in a validation role in a pharmaceutical or medical device industry.
  • In depth knowledge of relevant laws and regulations associated with the medical device industry (including FDA 21CFR regulations/ CE)
  • Competent working knowledge of recognized Quality Management Systems (ISO9001/ ISO13485/ ISO14971/ GMP).
  • Working experience of validation computer systems for use in FDA regulated environments.

For further information on this Senior Validation Engineer role in Galway please contact Clara Burke on 086 8168273/ science@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Clara Burke

JOB-11557

Senior Validation Engineer

Clara Burke

Role Type Permanent
Contact Clara Burke
email science@hero.ie
mobile +353 86 816 82 73
linkedIn profile click here

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