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JOB DETAILS

Title:
QA Validation Engineer
Location:
Mayo, Sligo
Job Type:
Mayo, Sligo

QA Validation Engineer

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below:

QA VALIDATION ENGINEER – Role based in Sligo

Responsibilities

To coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.

  • 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.
  • Creation/Review/Approval of various quality documents and test data.
  • Management of validation, exception event, and change control processes.
  • Maintenance and tracking of validation equipment, if applicable.
  • Completing all required training before executing a task.
  • Documenting all activities in line with cGMP requirements.
  • Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
  • 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.
  • Coordinating activities to maximize the effectiveness of all of the team members.
  • Maintaining the overall cGMP compliance of the production areas.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Requirements

Essential Requirements

  • Qualification and/or degree in engineering or scientific discipline.

Technical/Business Knowledge -Job Skills/Experience Required

  • 3 years plus validation/Quality experience in medical device plastics processing, 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.

We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated QA Validation Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.

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