Location: Cork Role: Contract Contract Length: 12 months
To support commissioning and qualification / validation activities on site at a leading Pharmaceutical manufacturing site. Support the Engineerng Department in maintaining validated process and validated equipment. The support includes managing projects, problem solving for manufacturing issues, and support of key site processes.
MAIN DUTIES AND RESPONSIBILITIES:
• Ensuring the site Validation Master Plan is updated and completed annually.
• Ensuring the Process Plan is updated and completed annually.
• Carryout the Site Periodic Review, which involves ensuring that each department reviews their system and reports on the quality and validation status of their system.
• Carryout validation and qualification on the following types of equipment;
? WFI (Water for Injection)
? Compress Air
? HVAC (Heating Ventilation & Air Conditioning) and Cleanroom classifications
? LAF (Laminar Air Flow) and Smoke Studies
? Vial Washers
? Filling Machines
? Cleaning validation on Process Vessels, Product Transfer Lines & parts
? CIP and SIP systems
• Trending of quality metrics to identify area of improvement.
• Ensuring all engineering systems operate as per validated process and ensuring all routine validation is completed on time.
• Write and execute all validation life cycle documentation all the way through from requirement specifications to test documentation to validation reports.
• Engineering or Science Honours Degree or equivalent knowledge & experience
• Proven years’ experience in validation within a GMP approved pharmaceutical or process industry with specific experience in commissioning and qualification of clean systems and manufacturing equipment.
• Good knowledge of and experience with Process Validation, Technical Documentation, Engineering Standards, and Guidelines.
• Experience in working in a GMP & GDP regulated environment.
• Experience in executing engineering projects