Senior Manufacturing Technician

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.

• Provide hands-on support and/or some leadership in the operation of equipment to support commercial manufacturing. Demonstrate initiative and ownership in achieving high-quality output on time.
• Coordinate equipment maintenance, calibration, and validation with appropriate internal departments. Troubleshoot equipment as necessary during production operations.
• Perform review and revision of SOPs and master batch record instructions to improve operational accuracy and efficiency.
• Execute SAP transactions in a commercial environment.
• Support in troubleshooting product and equipment issues and deviations. Lead / assist in providing timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions. Participate in root-cause analysis and CAPA activities.
• Interact cross-functionally with Upstream/Downstream Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful commercial manufacturing campaigns. Communicate effectively across levels and influence for best outcomes.
• Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines. Apply a process-centric approach and demonstrate flexibility toward continuous improvement initiatives.
  

• High School Diploma or equivalent with 3+ years relevant experience in a specific area in biopharmaceutical/ pharmaceutical manufacturing operations OR a combination of equivalent education and work experience.
• Previous experience with GMP commercial product manufacturing of pharmaceutical products. Specific knowledge in buffer/media preparation, autoclaving, and/or raw material sampling is a plus.
• End-User experience and/or knowledge in SAP Process systems as used in a regulated manufacturing environment (not IT SAP role).
• Ability to identify, investigate, and resolve basic process and equipment problems.
• Strong working knowledge of international (21CFR, EMEA, and JP) cGMP regulations.
• Ability for weekend rotation and few long process days.
• Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Biologics Operations.
• Self-starter with a strong focus on detail, safety, quality and results. Demonstrates grit and persistence in overcoming obstacles.
• Strong written and verbal communication skills. Presents information clearly and tailored to the audience.

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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://careers.eisai.com/us/en/compensation-and-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.

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