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_