Overview:
This person is part of the team supporting commercial manufacturing with a focus on Vial filling equipment, reporting to the Principal Engineer. The position will support complex and challenging manufacturing initiatives as a member of the Process & Equipment Engineering team.
Key Responsibilities
1. Ownership of equipment/systems in a GMP regulated manufacturing setting
2. Support Drug Product manufacturing within the Vial Filling area
3. Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
4. Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems
5. Solving complex problems, project management, equipment lifecycle management and operational excellence
6. Develop and manage change control requests per established SOPs and processes
7. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Preferred Qualifications:
1. Bachelor's degree in Engineering (Mechanical, Electrical or Chemical)
2. Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
3. Solid leadership, technical writing, and communication/presentation skills
4. Experience in change control, non-conformance, corrective and preventative actions, and validation practices
5. Experience in developing strategies for new product introduction and new technology deployment
6. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
7. Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
8. Ensure application of corporate blueprint and standards using business drivers to local business needs
9. Development and presentation of project plans to senior management
10. Day to day vendor management and contract negotiations with focus on equipment suppliers
11. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
12. Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Travel at various times may be required to support execution of projects.