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.

Cross trained in Operations, performs associated tasks as business requires

Identifies, pursues, and leads continuous improvements and special projects.

Requirements :

Bachelor's degree or equivalent level of skill and experience in an applied science

7+ years' work experience in pharmaceutical manufacturing required.

Knowledgeable of Metrology / Calibration

Knowledge of Validation principles

Experience with Validation data acquisition systems

Experience leading contractors / direct reports.

Previous GMP and GDP experience required.

Working knowledge of Metrology and / or Facilities databases required

Strong understanding of industrial / pharmaceutical instrumentation, equipment, and measurement principals, as well as process controls

Ability to specify new or replacement instrumentation and standards to support new projects or existing.

Strong troubleshooting and problem-solving skills; ability to analyze and diagnose instrument failures.

Willingness to learn and ability to translate learning into process and systemic improvements and innovation

Demonstrated ability to multi-task and successfully manage multiple priorities.

Results oriented; high level of initiative and ability to work independently with limited instruction and oversight. May require occasional general instruction on non-routine tasks or projects.

Works well with others and possesses the ability to build and maintain positive relationships.

Demonstrated ability to work in a team environment and lead a team.

Highly organized with focus on quality / attention to detail.

Strong written and verbal communication skill required.

Experience in writing deviations and / or strong technical writing experience required.

Proficient in Microsoft Office and Blue Mountain

Ability to lift or relocate machinery as needed.

GMP Production experience

Ability to lift 50 lbs.

Experience / Knowledge with AI

Eisai Salary Transparency Language :

The base salary range for the Associate, Technical Operations is from : 67,700-88,800

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https : / / us.eisai.com / careers-at-eisai / benefits .

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information :

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