Process Equipment Engineer
This position plays a critical role in supporting commercial manufacturing with a focus on Vial filling equipment.
The Process Equipment Engineer will be part of the team responsible for complex and challenging manufacturing initiatives, ensuring compliance with GMP regulations. This role involves:
Key Responsibilities:
* Ownership of equipment/systems in a GMP regulated manufacturing setting.
* Supporting Drug Product manufacturing processes.
* Leading and supporting system improvements, development of detailed specifications, engineering documents and standard operating procedures.
* Leading technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems.
* Solving complex problems, project management, equipment lifecycle management and operational excellence.
* Developing and managing change control requests per established SOPs and processes.
* Ensuring a safe working environment by complying with all pertinent environmental health/safety practices, rules and regulations.
Required Skills and Qualifications:
* Bachelor's degree in Engineering (Mechanical, Electrical or Chemical).
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
* 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.
Preferred Qualifications:
* Experience in developing strategies for new product introduction and new technology deployment.
* 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.