4 operator i jobs found in Cincinnati, OH

Alkermes, Inc. Support preventive action, development, engineering, and ongoing manufacturing efforts regarding quality and efficiency. Responsibilities Monitor active manufacturing batches, process trends, and floor activities to ensure safe, compliant, and efficient fill/finish operations. Provide real-time technical support and troubleshooting of batch issues, equipment concerns, and process deviations. Lead and support continuous improvement initiatives and change control activities. Support and/or lead non-routine on-the-floor activities including engineering studies, proof-of-concept runs, equipment testing, and safety improvements. Act as a manufacturing liaison with project Planning, Engineering and Technical teams. Develop and maintain process monitoring and trending tools; perform periodic review of data to identify opportunities to improve performance and efficiency Identify unfavorable trends, investigate root causes, and support the development and...

Alkermes, Inc. This position is based in Wilmington, OH We are seeking a qualified candidate for this position, which is available on both the 1st and 2nd shifts. While we will consider applicants for either shift, preference will be given to those available for 2nd shift. Summary: Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job Description: Read and follow detailed written SOP's/MPR's/Procedures. Document all work as required by cGMP's on a timely basis. Execute tasks as directed with...

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....