Project Process Engineer
Reference: SMC3795, Location: Carlow, Qualification: Degree, Experience: See description, Job Type: Fixed Term Contract, Salary: Not Disclosed.
We are currently recruiting for an exciting opportunity with a leading multinational based in Carlow. This is an excellent position for anyone looking to join one of the best companies in the industry.
Duties:
1. Manage multiple projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects.
2. Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
3. Develop 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.
4. Be 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.
5. Drive and support 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.
6. Act 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.
7. Comply 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.
8. Presentations and reporting out on progress of projects to stakeholders as required.
Education & Experience:
1. Bachelor's degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
2. Green Belt preferable.
3. 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.