Instrumentation Engineer

2 months ago

Waltham, United States Alkermes Full time

Position Summary:
Alkermes is currently seeking askilled  Instrumentation Engineer to join their Waltham facility. The individual will primarily be responsible for planning, installing, monitoring and maintaining the instrumentation and process equipment within a newly built Clinical Oral Solid Dose manufacturing suite. The ultimate aim of Instrumentation 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.

Support all phases of the clinical manufacturing process. Serve as the primary contact / liaison with the clinical manufacturing team to develop engineering requirements, maintenance/contractor work, and resource availability. Screen and evaluate incoming and outgoing responses as appropriate. 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. Locate and diagnose failures. Work through process to replace defective components including the completion of associated documentation, calibration and follow up tasks. Continually monitor and support equipment operations of the manufacturing suite and facility.  Coordinate and supervise all OSD process equipment maintenance and calibrations. Ensure process equipment operations comply with quality parameters.  Champion process improvement, commissioning, and qualification activities. 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.  Experience and Knowledge in troubleshooting and use of control systems, including PLCs, BAS, DCS, SCADA and related software.  Experience with information technology infrastructure components as they relate to industrial automation systems. Strong hands-on mechanical and electrical aptitude to understand and troubleshoot the equipment and machinery with which our systems interface. Previous field engineering experiences a plus. Experience in process, laboratory, and/or analytical instrument service with an understanding of diagnostics, calibration, and or repair. Engineering experience of standard DDC IO signaling and control, control wiring and process machinery General knowledge of pharmaceutical operations and equipment validations, in-depth knowledge of facility and utility validations.  Experience with CGMP documentation lifecycle and process. Familiarity with industry standards and regulations such as ISA, ISPE, IEC, and NEC.  Ability to create, read and interpret engineering drawings related to electrical instrumentation & controls using applicable software such as AutoCAD, Revit, Navisworks, Bluebeam, SKM or other relevant engineering software required.  The ability to work independently as well as on a project team.

Education and Experience:

BS in Engineering or a related field of study. Education may be substituted with industry experience of 5-10 years in Instrumentation & Controls. 5+ years of experience in a CGMP pharmaceutical manufacturing setting. Oral Solid Dose experience is a plus.  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.

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