Senior Manufacturing Technician
Vacancy expired!
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.and.#39;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 differenceand.nbsp; If this is your profile, we want to hear from youand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; JOB SUMMARY.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; The Senior Manufacturing Technician will be responsible for the performance of all critical manufacturing steps in production scheduling, material staging, equipment set-up , and GMP operations in the Support Operations group. The Sr. Manufacturing Associate will execute the preparation of media/buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and preparation of process equipment using a washer and autoclaveand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; ESSENTIAL FUNCTIONS.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Provide hands-on support and/or some leadership in the operation of equipment to support commercial manufacturingand.nbsp; Coordinate equipment maintenance, calibration, and validation with appropriate internal departmentsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Perform review and revision of SOPs and master batch record instructions to improve operational accuracy and efficiencyand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Execute SAP transactions in a commercial environmentand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Support in troubleshooting product and equipment issues and deviationsand.nbsp;.and.nbsp; Lead / assist in providing timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actionsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Interact cross-functionally with Downstream Operations, Upstream Operations, Facilities, R.and.amp;D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful commercial manufacturing campaignsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelinesand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; REQUIREMENTS.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Minimum of 3 years.and.nbsp; experience in BUFFER/MEDIA SUPPORT OPERATIONS at a pharmaceutical or biotechnology company.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Proficient in weigh, dispense, and sampling procedures for controlled raw materials.and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Proficient in the operation of all area specific production equipment such as washers, autoclaves, and disposable mixing technology for media and buffer solutionsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; End-User experience and/or knowledge in SAP Process systems as used in a regulated manufacturing environment (not IT SAP role).and.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Ability to identify, investigate, and resolve basic process and equipment problemsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Strong working knowledge of international (21CFR, EMEA, and JP) cGMP regulationsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Support Operationsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Self starter with a strong focus on detail, safety, quality and resultsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Strong written and verbal communication skillsand.nbsp;.and.nbsp;.and.nbsp;.and.nbsp; Eisai is an equal opportunity employer and as such, is committed in policy
Vacancy expired!