Equipment Engineer

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) 
•    Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
•    Solid leadership, technical writing, and communication/presentation skills 
•    Experience in change control, non-conformance, corrective and preventative actions, and validation practices
•    Experience in developing strategies for new product introduction and new technology deployment
•    Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
•    Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
•    Ensure application of corporate blueprint and standards using business drivers to local business needs
•    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