Validation Lead

https://www.teamhorizon.ie/job-search/1400-validation-lead/engineering/dublin/job2024-08-21 12:57:112052-01-05Team Horizon
Job TypeContractor
AreaDublin, IrelandDublinIreland
SectorEngineeringQuality
Start Date
AdvertiserAshling Guthrie
Job Ref3372
Job Views176
Description

Team Horizon is seeking a Validation Lead for a large-scale Fill Finish Project in the Pharmaceutical Industry..


 


Why you should apply:



  • This is an excellent opportunity to leverage your people management skills and lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

  • Work in a state of the art facility with a talented & diverse team


 


What you will be doing:



  • Coordinates and Supervises all Validation activities

  • Approves Validation planning documents detailing overall strategy for the projects

  • Develops and approves the master list of Validation test documents and activities.

  • Reviews and Approves all C&Q summary reports and Validation Summary reports.

  • Ensures the Validation schedule is developed and maintained

  • Ensures all Validation Engineers who perform Validation activities have relevant training assigned.

  • Pre-Approval and Post approval of Validation test documents.

  • Manages Validation coordination meetings.

  • Responsible for Overall Tracking and Reporting of Validation status and risks/issues

  • Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)


 


What you need to apply:



  •  BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality

  • Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical/Biotechnology projects

  •  Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.

  • Demonstrated strong Communication and Leadership skills.

  • Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.

  • Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry

  • In-depth understanding and application of validation principles, concepts, practices, and standards. • In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing

  • Working knowledge of sterilization/decontamination systems and industry practices.

  • Experience with AVS (Airflow Visualization) Studies.

  • Experience of aseptic processing


 


 

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