Senior Equipment Specialist
This role is part of a team supporting commercial manufacturing with a focus on Vial filling equipment. The position will support complex and challenging manufacturing initiatives.
* Responsibilities include ownership of equipment/systems in a GMP regulated manufacturing setting, Support Drug Product manufacturing processes, lead 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.
Main Responsibilities:
* Equipment Lifecycle Management
* Operational Excellence
* Project Management
* Solving Complex Problems
Requirements:
* Bachelors degree in Engineering (Mechanical, Electrical or Chemical)
* Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
* Solid leadership skills, technical writing, and communication/presentation skills
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Preferred Qualifications:
* Leadership skills for developing strategies for new product introduction and new technology deployment
* Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
* Team player able to work in collaboration for effective decision-making