21 Feb
Senior Manufacturing Technician
Pennsylvania, Exton 00000 Exton USA

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!


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