CQV Engineer

Engineering professional with excellent experience developed across the Oil & Gas, Pharma, Med Tech and Bio-Pharma sectors. Actively seeking both permanent and contract based opportunities in the Munster region.

Initially this candidate developed their career working as an E & I and Maintenance Technician/Engineer. During this time they worked extensively within the Pharma & Oil Gas sectors, providing key support that included multiple equipment inspections as well testing and pre-commission of all new equipment. They continued to develop their skills within this area gaining more and more experience that crossed into commissioning, qualification and validation of new equipment, processes and utilities within the Life Science sector.

For the last 3 years they have been working purely within CQV based roles in the Life Science sector, where key skills and projects would include:

• Document preparation of commissioning, qualification and validation for process, equipment and clean & black utilities.
• Field execution of commissioning and validation (CQV) for process & equipment
• Co-ordination of vendor packages to achieve streamlined CQV
• Co-ordination/review of construction packages
• Knowledge of recent regulations and modern CQV practices
• Completion and execution of IQ OQ PQ protocols in API & OSD pharmaceuticals
• Provide support to the C&Q team to ensure all activities are performed in accordance with the Quality Management System
• Ensure that all maintenance and calibration works are carried out in accordance with cGMP regulations
• Develop, review and update SOPs, Maintenance work instructions, Preventive maintenance checklists
• Support and contribute to lean initiatives and continuous equipment improvements
• CMMS data entry and monitoring QBMS systems. (Quality by Design)
• Monitoring and maintenance of cleanrooms to ISO 14644 guidelines (URS)
• Assist with commissioning of new assembly line (IQ, OQ, PQ)
• Monitoring processes to ensure they are effective (OEE, Root Cause analysis, Lean)
• Making sure CIP cleaning system is operating to all parameters