Project Process Engineer
We are seeking a highly skilled Project Process Engineer to join our team at {company} in Carlow. This is an excellent opportunity for someone who is looking to work with a leading multinational organization that specializes in pharmaceuticals.
Duties include:
* Managing multiple projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects.
* Using scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
* Developing project scope, cost and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or Technical transfers.
* Being accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs, and requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
* Driving and supporting continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
* Acting as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
* Complying with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
* Presentations and reporting out on progress of projects to stakeholders as required.
Education & Experience:
* Bachelor's degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
* Green Belt preferable.
* Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects.
Salary: €80,000 - €100,000 per annum.