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Validation Engineer

  1. Cork
County Sligo
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
18-07-2024
34213
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Validation Engineer - Pharmaceuticals - Sligo, Ireland - 18-Month Contract

Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Validation Engineer to join their state of the art pharmaceutical facility.

Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports



Responsibilities: 
  • Coordination / direction and active participation in the validation and qualification of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
  • Generation of validation and qualification protocols and final reports to cGMP standards.
  • Generation of validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various qualification documents and test data.
  • Management of validation, exception event, and change control processes.
  • Maintenance and tracking of Engineering equipment, if applicable.
  • Completing all required training before executing a task.
  • Documenting all activities in line with cGMP requirements.
  • Updating of Engineering procedures, job instructions and forms 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 maximise the effectiveness of all of the team members.
  • Maintaining the overall cGMP compliance of the engineering areas.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
  • Required to work as part of cross functional internal and corporate teams.
 
Requirements: 
  • Extensive validation experience in medical device plastics processing, moulding or assembly operations.
  • Experience in a cGMP regulated environment.
  • Knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Experience of validating in a highly automated environment.
  • Strong communication (written and oral), presentation and troubleshooting skills required.
  • Effective interpersonal and organisational skills.
  • Ability to work well both independently and in a team environment.
  • Capable of prioritising work and multitasking.  

If this role is of interest to you, please apply now! 


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