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Job #02845

About our client Our client is a globally recognized medical device company headquartered in Ohio for over 100 years. They specialize in manufacturing devices for patients that are easy to use and affordable. They have many products on sale on the market today! They boast a 58 square-foot state-of-the-art manufacturing facility, an experienced management team and an excellent development program. This is a great opportunity for the successful candidate! Position Location Process and Equipment Engineering Manager Cleveland, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist the management of day-to-day functions of all engineering and maintenance technicians and equipment specialists 2) Design, create, modify, install and maintain the equipment and systems required for manufacturing products to comply with all applicable regulatory requirements 3) Coordinate and assist with designing, fabrication, acquisition, installation and validation of equipment 4) Manage installation qualification, operational qualification and performance qualification documentation as well as drawings required for compliance with current cGMPs and ISO 5) Work as Project Manager or as a team member providing support activities, in a thorough and time-effective manner 6) Evaluate, recommend and manage implementation of technical enhancements to strengthen manufacturing operation capabilities, optimize processing methods, ensure process reproducibility, improve batch yields and reduce process cycle times 7) Utilize established statistical process control methods and techniques to assess the effectiveness of manufacturing systems 8) Comply with the company’s documentation system of SOPs drawings to adhere to regulatory requirements 9) Manage the implementation of preventative maintenance plans for all manufacturing equipment and systems 10) Play a major role in the investigation, review and remediation of system and/or equipment failures 11) Assist the Manufacturing Manager to train employees in the operation of new equipment 12) Develop SOPs and/or other related documentation (as required) 13) Maintain an ‘Engineer for Safety’ mentality for all equipment designs and process implementations 14) Assist with safety training programs (as required) 15) Participate in proactive team efforts to achieve departmental and company goals 16) Assist with internal and external audits (as required) 17) Comply with all company policies, practices and procedures 18) Perform other duties as assigned by the Director of Development and Engineering or the President Requirements 1) Bachelor’s degree in Biochemical, Chemical or Mechanical Engineering 2) 5 – 7 years of experience in progressively responsible engineering positions in the medical device or pharmaceutical industry 3) Previous management experience (people and projects) 4) In-depth knowledge of GMP and ISO requirements as well as the validation process 5) Knowledge of installation qualification, operational qualification and performance qualification 6) Ability to organize and lead project teams along with prioritizing tasks 7) Familiarity with aerosol gas handling, aerosol filling and the packaging and labeling equipment required for medical devices 8) Ability to read and understand pneumatic, electrical and mechanical drawings 9) Flexibility to deal with issues (functional and/or managerial) at the necessary level 10) Highly organized, accurate and detail-oriented 11) Ability to handle multiple projects simultaneously 12) Proficiency in MS Office, AutoCAD and basic computer skills 13) Superb interpersonal and management skills