Aphex currently seeks Commissioning & Qualification Engineers that will work in the areas of Commissioning and Qualification of pharmaceutical manufacturing equipment and processes within the Cork region.

Job Requirements /Accountabilities:

• Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)
• Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
• Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget
• Review and modification of standard operating procedures (SOPs) for various equipment
• Manage project documentation such as protocols, reports, calibration certificates, and process trends
• Facilitating and expediting construction handover/ mechanical completion
• Liaising with/co-ordinating vendors, contractors and the site team to complete all scope of works
• Ensuring the installation and operation of your equipment/system meets project and client requirements

Qualifications

• BS or MS in Engineering or related discipline
• 3+ years in validation, quality systems, operations, engineering or any combination
• Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge
• Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards