JOM32500 Project Engineer Dublin
The Project / Equipment Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Labelling and Packaging areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.
Key Responsibilities
1. Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
2. Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will NOTAG from concept, through design, construction, commissioning and operation
3. Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
4. Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
5. Ability to translate strategic/emerging technology solutions into pragmatic executable plans
6. Development and management of change controls
7. Participate as a member of multidisciplinary site and multisite teams
8. Lead on the floor execution for project delivery, micro planning scheduled activities in critical non commercial windows.
9. Development of detailed specifications, engineering documents, protocols and standard operating procedures
10. Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
11. Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
12. Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures
13. Support a safe working environment by complying with environmental health/safety practice, rules and regulations
14. Travel may be required to support execution of projects
Experience and Qualification:
15. Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience
16. Typically, 5+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes.
17. Device assembly / Packaging Experience preferred.
18. Technology transfer experience preferred.
19. Proven project management experience.
20. Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
21. Demonstrated experience in a GDP Compliant environment.
22. Experience in MS Office, MS Project, Change Control & Document Management Systems
23. Proven ability working cross functionally, delivering technical solutions and implementing improvements.
24. Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
25. Technical report writing and communication/presentation skills
26. Data driven decision maker
27. Ability to work to tight deadlines in a fast-moving environment
If interested please feel free to contact Joan O’Malley on joan.omalley@lifescience.ie or +353 87 189 7333 for further information.