西神エンジニアリングSeishin Engineering/課長 Senior Manager/M1 at Lilly

Kōbe, Hyogo Prefecture, Japan -

Full Time

Start Date

Immediate

Expiry Date

13 Jun, 26

Salary

0.0

Posted On

15 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Engineering Management, Maintenance, Validation, Environmental Control, GMP, Talent Development, Technical Improvement, Deviation Management, Change Proposals, Process Development, Technical Oversight, Staff Qualification, Process Characterization, Quality Assurance, Leadership, Communication

Industry

Pharmaceutical Manufacturing

Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. 職務概要** Engineering Manager is responsible for the management of Engineering Group. In order to keep the continual supply of high-quality finished products to the Japanese market, which meet the respective regulatory requirement, this position is accountable for supervising the control over maintenance, validation and environmental control, utilizing sufficient knowledge and experience for GMP issues. They’re also responsible for talent development. 職務内容** Responsible and owns of engineering documents, training, and activities. Plans for technical GMP improvement to be conducted at Engineering, and control and check the implementation. In case of technical issues such as deviations and change proposals in packaging area, technically control the process to assure the quality. Develop local processes and procedures in accordance with Engineering management system. Provides technical oversight and stewardship for the production operations, Ensures staff are qualified and that the required initial and continuing training of technical support personnel is carried out and adapted, according to need, to ensure appropriate operations support. Ensures the process and product are well characterized and that the process description and control strategy, including the measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications) have been documented in a process flow document (PFD) or its equivalent. Ensures that the processes, facilities, equipment, or systems for which they are responsible have been validated or qualified, and Ensures that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state. 応募資格** Bachelor grade or equivalent in engineering, scientific background. • Minimum 5 years experience in manufacturing environment • Knowledge of GMP, Pharmaceutical Science, Pharmaceutical Law, Finance • Strong Communication Skills • Fluent English / Japanese (written/verbal) • Leadership capability in management of group members and execution of improvement work. • Ability to influence at all levels of organization • Ability to maintain rapport with internal and external partners • Cross-functional communication skill Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly

Responsibilities

The Engineering Manager is accountable for supervising maintenance, validation, and environmental control to ensure the continual supply of high-quality finished products meeting regulatory requirements for the Japanese market. This role also involves owning engineering documents, planning technical GMP improvements, and developing local processes and procedures.