4 systems engineer jobs found

Alkermes, Inc. The Senior Systems Analyst role will drive the design, deployment, and support of manufacturing computer systems and integrated equipment at the Alkermes Wilmington facility. The successful candidate will build strategic business partnerships, drive business value, and foster a culture of innovation and compliance. Responsibilities Oversee and support the implementation and lifecycle management of vendor integrated & skidded equipment and other manufacturing computer systems. Design, deploy, and maintain computer systems and supporting infrastructure to meet manufacturing, compliance, and reliability requirements. Serve as a subject matter expert for assigned technical systems. Partner with crossfunctional teams including Operations, Engineering, Validation, Quality and Facilities to ensure system accuracy, data integrity, business continuity, and alignment with operational needs. Troubleshoot and resolve complex hardware, software, and...

Alkermes, Inc. Job Summary The Senior Engineer, Oral Solid Dosage (OSD) Manufacturing Science and Technology (MSAT), serves as the process technical authority for critical OSD unit operations, with a primary focus on blending, tablet compression, and lowshear wet granulation via topdown spray fluid bed systems. This role is responsible for deep technical ownership of these processes across the product lifecycle, including commercial manufacturing support, technology transfer, troubleshooting, process optimization, and continuous improvement. The position partners closely with Manufacturing, Quality, Engineering, and Process Development to ensure robust, compliant, and capable processes that consistently deliver highquality product. The ideal candidate is a recognized subject matter expert (SME) who can translate scientific and engineering principles into practical, shopfloor solutions while maintaining strong regulatory and GMP alignment. Responsibilities Process...

Alkermes, Inc. Job Description - Engineer, Mechanical Responsible for supporting the growth and ongoing operation of the site facility as the technical owner of HVAC systems. Ensure the proper design and modification of HVAC systems to deliver the capability to consistently meet internal customer demands in a safe & compliant manner. Responsible for supporting the operation of the facility by assisting in troubleshooting /optimization of plant systems. This position will work closely with Project Management, Maintenance, Facility and Process System Owners, Site Operations, EHSS & Supply Chain to establish user requirements, discipline related strategies, assist with budgets, and key schedule milestones for project activities. Project activities are supported through a combination of matrixed and dedicated internal and external resources, and the position requires close and open communication with all parties including key stakeholders. Major Duties/Responsibilities:...

Alkermes, Inc. Summary This position will support and assist in manufacturing pharmaceutical products for commercial and clinical supplies. Key duties include scale-up and transfer of oral solid dosage formulations/processes to the production facility, designing and recommending equipment purchases, and writing and executing equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes. Develop and implement SOPs in support of new and upgraded processes. Champion projects as they move into and through the manufacturing areas....