GENERAL DESCRIPTION:

Alkermes is currently seeking askilled  Process Automation Engineer to join their Waltham facility. The individual will be responsible for the design, programming, monitoring and maintenance of production and facilities process automation systems. Job duties include configuration and support of PLC code, resolution of automation equipment issues and adherence to standard operating procedures (SOP’s) in a GxP regulatory environment. The ultimate aim of Process Automation Engineer is to ensure that control machinery and process equipment are working to achieve maximum productivity in an optimally efficient, safe, compliant, and reliable manner. This is located onsite in our Waltham facility. KEY DUTIES: Assist in the planning, development, and deployment of automation solutions for on-site equipment Provide run-the-business automation equipment of manufacturing systems including after-hours on-call Write and edit design documentation, both functional and detailed specifications Assist with the start-up, commissioning, and validation of automation systems Monitor existing system performance and implement industry best-practice improvements Ensure high Good Manufacturing Practices (GMP) and Environmental Health and Safety (EHS) standards are maintained, while adhering to schedules to meet the business requirements. Assist as needed in regulatory agency inspections. Development of standard operating procedures and production staff training if required. On-Call and Emergency Response. Respond to a variety of problems that may and do occur. Locate, determine, and correct problems or contact appropriate personnel for assistance. On-Call duties responding to emergencies 24 Hours/Day. On-Call rotation usually no more than once per month. Support the Site Operations team as needed. BASIC QUALIFICATIONS

EDUCATION AND EXPERIENCE: Bachelor’s degree or higher preferred (Engineering or Computer Science) Automation manufacturing systems experience (3-5 years) Oral Solid Dose experience is a plus. Experience with Rockwell FactoryTalk or comparable software systems required PLC and HMI programming experience required Experience with Siemens PLC automation systems a plus Experience with ANSI/ISA-88 batch process control standards a plus Experience and support for 21CFR part 11 and Good Manufacturing Practices desired Able to navigate interpersonal communication and compose clear and professional written business correspondence. Strong attention to detail and focus on quality, accuracy, and accountability. Possess personal qualities of integrity, credibility, and commitment to the organization’s mission, vision, and values. PREFERRED QUALIFICATIONS

Physical Requirements: Ability to lift/move 40 lbs. overhead. Must be able to be medically cleared for respirator use (PAPR) Ability to operate different types of production equipment. Ability to gown correctly for clean room manufacturing operations. Ability to stand or sit for extended periods (up to 4 hours at a time). Must be able to work in an office and a manufacturing environment. Some travel required ( Must be able to work onsite in our Waltham facility #LI-TS1