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Senior Validation Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeValidator Full time €60,000 - €75,000
Validation Engineer

We are seeking a highly skilled Validation Engineer to join our client's team at their facility in Ireland.

Key Responsibilities:

  • Coordinate the development and maintenance of site validation programs to ensure AbbVie and external regulatory requirements are met.
  • Coordination, implementation, and active participation in the site Validation Program and general Quality Assurance activities.
  • Generate/maintain/execute of Site Validation Master Plans and Project Validation Plans and schedules.
  • Generate 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.
  • Manage validation, exception event, and change control processes.
  • Maintenance and tracking of validation equipment.
  • Complete all required training before executing a task.
  • Document all activities in line with cGMP requirements.
  • Update validation procedures, job instructions, and batch documentation to reflect current best practices.
  • Perform cross-training within the team and training of new team members.
  • Participate in continuous improvement programs to implement improvements.
  • Coordinate activities to maximize the effectiveness of all team members.
  • Maintain overall cGMP compliance of production areas.
  • Communicate with peers and management regarding activities in the area.

Essential Requirements:

  • Qualification in engineering or scientific discipline.
  • 3+ years of validation/Quality experience in medical device plastics processing, moulding, or assembly operations.
  • 3+ years of knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Strong communication, 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.

Benefits:

This role offers an exciting opportunity to work in a fast-paced environment, collaborate with experienced professionals, and contribute to the success of our client's organization.

How to Apply:

For more information about this position, please contact us.