Career Category: Engineering
Job Description:
Overview:
Reporting to the Principal Engineer, this person is part of the team supporting commercial manufacturing with a focus on Vial filling equipment. The position will support complex and challenging manufacturing initiatives. As a member of the Process & Equipment Engineering team, the role will support complex and challenging manufacturing initiatives.
Key Responsibilities:
* Ownership of equipment/systems in a GMP regulated manufacturing setting
* Support Drug Product manufacturing within the Vial Filling area
* Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
* Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems
* Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs
* Solving complex problems, project management, equipment lifecycle management and operational excellence
* Develop and manage change control requests per established SOPs and processes
* Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Preferred Qualifications:
* Bachelor's degree in Engineering (Mechanical, Electrical or Chemical)
* Development and presentation of project plans to senior management
* Day to day vendor management and contract negotiations with focus on equipment suppliers
* Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
* 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.