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The 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 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 autoclave.
• Provide hands-on support and/or some leadership in the operation of equipment to support commercial manufacturing.
• Coordinate equipment maintenance, calibration, and validation with appropriate internal departments.
• 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.
• interact cross-functionally with Downstream Operations, Upstream Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful commercial manufacturing campaigns.
• Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines.
• Minimum of 3 years’ experience in buffer/media support operations at a pharmaceutical or biotechnology company
• Proficient in weigh, dispense, and sampling procedures for controlled raw materials
• Proficient in the operation of all area specific production equipment such as washers, autoclaves, and disposable mixing technology for media and buffer solutions.
• 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.
• Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Support Operations.
• Self starter with a strong focus on detail, safety, quality and results.
• Strong written and verbal communication skills.
Eisai requires all contractors providing services to Eisai to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law. This requirement is a condition of providing services to Eisai, and it applies regardless of whether the contractor is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualified medical reasons (including pregnancy-related) or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation from your employer/supplier.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.