Nature and scope Working as part of a multi-disciplinary team, the Process Engineer must possess the ability to manage multiple tasks simultaneously, manage projects and project timelines, and create project specific documentation, drive project procurement, implementation, and project closure in an FDA regulated environment. This position will be required to develop procedures and systems to assure operations and maintenance meet GMP and operational efficiency requirements as well as lead efforts to identify opportunities for operational improvement and possess the ability to solve technical issues that arise. This position will support both our commercial and, as required, our Research & Development operations. This position is a hands-on position and will focus on supporting equipment and processes required to support an aseptic manufacturing operation. This individual must possess a willingness and ability to grasp new concepts and systems quickly and provide Subject Matter Expertise on those systems once knowledge is acquired. This position requires the ability to chair meetings, present topics to the leadership team, provide constant, thorough and professional communication throughout all levels of the organization. Work with manufacturing personnel to develop, review, revise, and maintain SOPs, operational, maintenance for all current process / packaging equipment and maintenance processes. Develop and work with Maintenance in developing a spare parts inventory Provide troubleshooting on process equipment issues. Assist and direct vendors and contractors as required on equipment within area of responsibility. Assure up-to-date drawings of new and/or existing equipment and processes. Assure compliance to GMP requirements, adherence to SOPs and use of the change control system. Assure all process and packaging equipment operates within parameters. Create and manage the scope development of projects / tasks (User Requirement Specifications). Support new production and development equipment through vendor activities during installation, commission and qualification activities. Closely interact with the maintenance technicians to develop, implement, and improve maintenance practices and procedures. Identify and track key process metrics to identify improvement opportunities. Develop and implement improvements through cross-functional interactions. Assist with EHS activities when applicable and appropriate. Qualifications and Requirements Bachelors' Degree in Engineering or related discipline required. Minimum of 5 years experience in Pharmaceutical Manufacturing or a related industry required. Ability to understand mechanical layouts and electrical/pneumatic schematics. Ability to troubleshoot process and mechanical systems (PLC experience considered an asset) Experience with customer interaction and coordination. Ability to prepare technical documentation / protocols. Computer proficiency (Microsoft Suite). Physical Environment and Physical Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the appli