30021-Validation Engineer-Athlone Contractor NEW

This is a 12 month contract.

Purpose:

The Thermal Systems Validation Engineer will prepare the necessary documentation and monitor progress for technical projects and validated status of the Thermal Systems equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms and CTUs) across the organization. The incumbent will be a contributor and Subject matter Expert (SME) in supporting the execution of the qualification studies relevant to the site thermal systems supporting aseptic manufacturing.

Responsibilities:

• Validation documentation – drafting, reviewing and approving Validation documentation.
• Manage contractors as per site contractor management procedures.
• Oversee, witness, and execute where required 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 the core aspects of Operations, Qualification and Validation SOP’s where required.
• Maintaining hardcopy records in Document control archive, including reconciliation of Documentation.
• Leading or supporting validation deviations as they occur.
• Supporting 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.
• Encourage and sustain a high safety culture and performance within the Validation team

Qualifications:

• Technical Degree in Engineering/Life Sciences
• 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.
• Demonstrated ability to work effectively with various departments and resolve issues in structured manner.
• Strong technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own.
• Goods 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