JOB OFFER

JOB DETAILS

Title:
Validation Engineer
Location:
Sligo
Job Type:
Sligo

Validation Engineer

GerTEK Project Management & Technical Services is one of Ireland’s leading Project Management and Technical Service companies. We are hiring for an experienced Validation Engineer to join our team.

Job Responsibilities

  • Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance/execution of the Site Validation Master Plan.
  • Generation/maintenance/execution of Project Validation Plans and schedules.
  • Generation of validation protocols and final reports to cGMP standards.
  • Generation of validation investigations and implementation of corrective actions.
  • Participate in validation of Laboratory Equipment and Test Method Transfer
  • Creation/Review/Approval of various quality documents and test data.
  • Management of validation, exception event, and change control processes.
  • Completing all required training before executing a task.
  • Documenting all activities in line with cGMP requirements.
  • Updating of validation procedures, templates and involvement in process improvements for Quality Organisation
  • Performing cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Education & Key Skills

  •    Engineering degree and/or equivalent qualification.
  • 3 years plus Validation/Quality experience in GMP manufacturing establishment ideally in moulding or assembly operations.
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the
    medical device industry.
  • Strong communication (written and oral), presentation and troubleshooting skills required
  •  Effective interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Capable of prioritizing work and multitasking.

 

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