Associate, Technical Operations

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.

Responsible for the Gliadel metrology/calibration program and activities. Will oversee a team of metrology consultants and/or vendors as needed. Ensure that all calibrations are done on time, according to established procedures and schedules, and that OOTs are thoroughly investigated and documented. Develops and evaluates quality and system standards within the department to ensure reliability and compliance with company standards and governmental regulatory requirements. Investigates/troubleshoots equipment/instrument issues and/or performance processes. Ensures that corrective measures meet acceptable reliability standards.

The position ensures that personnel training is adequate and up-to-date. They work closely with external and internal groups and coordinate calibration activities to support ongoing compliance, validation activities, operations activities, maintenances schedules, new equipment/instrument installations, daily production activities, documentation generation, and special projects. This position will require duties outside of Metrology to include but not be limited to validation/revalidation activities, cross training in operations and execution of production processes, lead process improvements and special projects. They ensure all appropriate documents are completed per Good Documentation Practices and enter appropriate information into electronic databases. This position will lead a Microsoft Power BI or AI initiative to trend EMS data for freezers, Process inventory and other data as available for all departments. Through the use of AI, this position will help streamline validation documentation by automating test script generation and tasks, enabling predictive risk assessments as needed for change controls for validated equipment, and intelligent documentation. They develop and maintain metrics, schedules, and timelines as well as drive Blue Mountain upgrades. They serve as a liaison between the Metrology function and Facilities, Quality, and Operations. The individual will serve as the Metrology Program subject matter expert for auditors and regulatory inspections.

Essential Functions:

• Oversees the Metrology department and is responsible for maintaining compliance of the Metrology program. 

• Oversight/scheduling of contract/consulting Metrology staff.

• Serves as SME and lead decision maker for the Metrology program, ensuring goals and tasks are met within.  Interact with regulatory agencies as needed. 

• Monitors and manages calibration program and technicians to ensure instruments and equipment are properly calibrated per the required schedule. Tracks progress and maintains appropriate metrics.

• Provides training on the Blue Mountain system to all new hires and is a training resource to all employees.

• Performs calibration record review

• Performs risk assessments for the Blue Mountain Quality Resource updates

• Utilizes AI to trend data on critical equipment across all departments, generate smart documentation such as protocols

• Participates and/or represents the site on global projects

• Ensures departmental training is appropriate and up to date. 

• Coordinates outside calibrations/schedule with vendors

• Serves as project manager for projects and improvements.

• Ensures that all applicable SOPs are in place and followed.

• Works closely with equipment owners to ensure that all documentation is complete and accurate

• Maintains Blue Mountain databases.

• Performs monthly lab audits

• Assists in development of Work Plan Templates/Measurement Data Templates

• Oversee Blue Mountain System Upgrades

• Drafts Validation Protocol and Final Reports

• Execute Validation/Revalidation studies

• Other duties as assigned such as batch record review and validation support.

• Ensures CAPAs and other changes are meaningful and effective.

• Support commercial production.

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