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Senior CSV Engineer
Confidential
- Tralee, Kerry, Ireland
- Tralee, Kerry, Ireland
À propos
The following information aims to provide potential candidates with a better understanding of the requirements for this role.
This state-of-the-art, highly sustainable plant will focus on the aseptic fill-finish and lyophilization of advanced biologics (mAbs and ADCs) and is now seeking a Senior CSV Engineer contractor to join the team.
The Role: Lead the validation of computerized systems, including the development and execution of Validation Plans, IQ/OQ/PQ protocols, and Summary Reports, specifically tailored to sterile manufacturing equipment.
Drive and implement system-related improvements to ensure predictable performance across core production areas, with a heavy emphasis on aseptic processing/filling, lyophilization (freeze-drying), and fill-finish systems.
Ensure data integrity and risk reduction across automated platforms, aligning manufacturing execution systems and equipment software with ALCOA+ principles and regulatory expectations.
Provide effective and responsive CSV support to Operations, Automation, and IT to meet site objectives regarding quality, regulatory compliance, and system uptime.
Required: Degree in Engineering or a Scientific related discipline.
6+ years of experience in a Pharmaceutical or Medical device manufacturing environment (must be GMP regulated). xyswxtq
Strong background in aseptic processing, sterile fill-finish, compounding, or lyophilization technologies is highly desirable.
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Compétences linguistiques
- English
Avis aux utilisateurs
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