Excellent Career Opportunity:
Process Engineer
This is an outstanding position for a skilled professional seeking to join a leading multinational organization in Dublin.
* The Process Engineer delivers technical support to the Drug Substance Business:
* leading investigations within the Integrated Process Team
* supporting key projects across the site
* supporting design, construction and qualification of upstream & downstream equipment
Main Responsibilities
* Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP)
* Design/Author/Review/Approve/Execute qualification documentation
* Lead experimental design of studies, execution, data analysis and interpretation
* Authors and reviews batch documentation, regulatory and technical documentation
* Interpret trends observed in commercial process monitoring
* Support the execution of development and PPQ batches, change control management and implementation
* Lead multidisciplinary teams for process improvement and troubleshooting
* Participate in audits and inspections
* Lead various initiatives to improve compliance status and operational efficiency
Requirements
* Bachelor degree in a scientific or engineering field
* Minimum 5 years of relevant post-degree work experience in GMP Manufacturing
* Prior experience in drug substance process development and process performance qualification
* Knowledge of process monitoring systems, automation systems and operational intelligence & data systems
Subject Matter Expertise in upstream/downstream processing and process control strategies.