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Job #02859

About our client Our client is a specialty pharmaceutical company focused on the development, manufacturing, and marketing of branded and multi-source pharmaceutical products. The company has an experienced management team, state-of-the-art facilities and a loyal customer base. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Lyophilization Engineer Illinois Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage overall engineering support and supervision of the lyophilization filling, capping, washing, and freeze-drying processes 2) Handle equipment and utility design analysis as well as recommendation and approval 3) Manage pre-validation of equipment and process characterization and commissioning (e.g. engineering runs) 4) Define associated equipment and instrumentation calibration needs and ensure/verify adherence to the criteria 5) Oversee establishment and consistent implementation of associated preventive maintenance procedures and requirements for associated equipment and utilities 6) Address technical and systemic issues using site-based investigative procedures and resources 7) Ensure that all cGMP training requirements are met on time for engineering activities 8) Document and/or review (associated) maintenance work orders, maintenance logs and similar documentation to ensure appropriate planning, authorization, execution and review of routine and non-routine engineering and maintenance activities 9) Ensure that site/corporate safety programming is effectively applied to the work environment 10) Provide engineering/technical support for associated equipment, utility, facility, process and software validation 11) Supervise and/or perform semi-annual HEPA filter integrity testing and clean room certification 12) Identify, recommend, plan/schedule, supervise and document-related outside engineering, maintenance and calibration service contractors as per established procedures 13) Participate in pre-FAT and IQ/OQ/PQ testing for new production equipment 14) Act as substitute for other production supervisory staff (in their absence) Requirements 1) Engineering degree with 2 years of related experience and/or training, or equivalent combination of education and experience 2) Minimum 2 years of recent lyophilization engineering and maintenance experience 3) Experience in a pharmaceutical manufacturing/lyophilization environment, or advanced mechanical training or education a plus 4) Strong mechanical aptitude 5) Ability to recommend cycle modifications to effectively solve finished product anomalies a plus 6) Adaptable to changes and ability to perform under pressure with time constraints 7) Good leadership and communication (verbal and written) skills 8) Ability to work as a team player