Validation Engineer
PE Global is currently recruiting for a Validation Engineer for a leading biopharmaceutical client based in Athlone.
About the Role
This is an initial 12-month contract position.
Responsibilities
* Prepare necessary documentation and monitor progress for technical projects and validated status of Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization.
* Draft, review and approve validation documentation.
* Manage contractors as per site contractor management procedures.
* Oversee, witness, and execute requalification activities on site Thermal systems.
* Participate in Validation Risk Assessments to determine the level of testing required for equipment changes or new equipment.
* Support sustaining and project Validation activities across Drug Substance and Drug Product Areas.
* Input into core aspects of Operations, Qualification and Validation SOP's where required.
* Maintain hardcopy records in Document control archive, including reconciliation of Documentation.
* Lead or support validation deviations as they occur.
* Support closeout of investigation actions for Validation team.
* Ensure Requalification and Periodic Review activities are completed in a timely manner.
* Provide support in areas of commissioning and qualification of HVAC systems where required.
* Report/present out on project updates as required.
Requirements
* 5+ years relevant experience working in a Validation role in the Pharmaceutical/Biotechnology industry.
* Good knowledge of EN285 and the kill kinetics of Stem Sterilization systems.
* Good knowledge of CTUs thermal mapping requirements.
* Strong technical capabilities, communication skills, teamwork abilities and initiative.
* Proven ability to work well as part of a team & on own.
* Good understanding of the requirements of ISO 14644 and how it supports aseptic manufacturing.
* Good Knowledge of VHP (Vaporized Hydrogen Peroxide decontamination systems)
* Understanding of the Aseptic Manufacturing processes
About Us
At PE Global, we understand that you want to have clarity on the job description and its process. We will give you feedback on your application.
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.