Automation Engineer - Pharmaceutical/Biotech
Company is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing Client technologies to produce state-of-the-art vaccines and therapies for people when they are most in need.
The Automation Engineer will be part of a team reporting to the VP of IT and will provide key support for various manufacturing, quality and research systems. This will include Programmable Logic controllers (PLC), PI Data Historian, IGNITION for data reporting & remote alarms, Single Use Bioreactors and Other Equipment Manufacturer (OEM) systems in Manufacturing, QC labs and Research Operations. This role will be responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs. This role will have the opportunity to lead projects in the deployment of new process and IT capabilities.
This role will lead automation-related investigations into Atypical Production Reports (APRs) and implement the corrective actions. Initial responsibilities include working with the startup team and providing technical leadership in fulfilling the automation requirements for a new - $40M GMP Manufacturing facility. For various project assignments/initiatives, the Automation Engineer is responsible for partnering with Quality Assurance and Manufacturing groups in maintaining CGMP requirements. The role provides multiple opportunities to learn new skills in IT, automation and process analytical technologies and help advance innovative gene therapies to patients.
Must be able to work and be on call off day shifts including weekends in rotation with 3 other engineers.
Key Responsibilities include, but are not limited to:
Education & Experience: