Thermal Systems Validation Engineer
This is what you will do:
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.
Key Responsibilities:
* Preparation, monitoring, and validation of technical projects and equipment (Stem Autoclaves, Depyrogenation Tunnels, Ambient Warehouses, Cold rooms, and CTUs) for our client.
* Acting as a Subject Matter Expert (SME) in qualification studies for thermal systems supporting aseptic manufacturing.
* Managing validation documentation, overseeing requalification activities, and participating in Validation Risk Assessments.
* Supporting Validation activities across Drug Substance and Drug Product Areas.
* Maintaining records, leading validation deviations, and ensuring timely completion of Requalification and Periodic Review activities.
* Providing support in commissioning and qualification of HVAC systems and presenting project updates.
* Promoting a high safety culture within the Validation teams.
Requirements:
* 5+ years of relevant experience in Validation within the Pharmaceutical / Biotechnology industry.
* Good understanding of EN285, Stem Sterilization systems, Autoclave, and CTUs thermal mapping requirements.
* Ability to work collaboratively, resolve issues effectively, and demonstrate strong technical and communication skills.
* Proven teamwork abilities and initiative.
Preferred Qualifications:
* Understanding of ISO 14644 and its relevance to aseptic manufacturing.
* Knowledge of VHP (Vaporized Hydrogen Peroxide decontamination systems) and Aseptic Manufacturing processes.
Education:
* Technical Degree in Engineering/Life Sciences.
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