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.

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:

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:

Right To Work

E-Verify Participation