JOB OFFER

JOB DETAILS

Title:
Validation Engineer
Location:
Mayo
Job Type:
Mayo

Validation Engineer

Validation Engineer

GerTEK Project Management & Technical Services are hiring for an experienced Validation Engineer to join our team.

Job Responsibilities

  • Updating of validation procedures, templates and involvement in process improvements for Quality Organisation
  • Participate in validation of Laboratory Equipment and Test Method Transfer
  • 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.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • 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.
  • Creation/Review/Approval of various quality documents and test data.
  • Completing all required training before executing a task.
  • Documenting all activities in line with cGMP requirements.
  • Performing cross training within the team and training of new team members.

Education & Key skill requirements

  • Bachelor’s degree or equivalent in Quality, Engineering, Science or related discipline.
  • 2 years plus Validation/Quality experience.
  • Strong communication (written and oral), presentation and troubleshooting skills required
  • Effective interpersonal and organizational skills.

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