BD (Becton, Dickinson and Company) Veterans Jobs

Job Information

BD (Becton, Dickinson and Company) 高级验证工程师_QA_宜兴_宜兴工厂 in Suzhou, China

Job Description Summary

Take the responsibility of site validation leader for ensuring site qualification and validation activities meet relevant QMS requirements and GMP requirements. And also involve in quality system set-up and maintenance.

作为验证负责人确保工厂的确认和验证活动满足相关质量体系要求和GMP的要求。同时参与质量体系建立和维护。

Job Description

KEY RESPONSIBILITIES (主要职责)

Set-up validation master plan (VMP) for greenfield factory

为新工厂建立验证主计划。

Set-up qualification and validation management procedure to ensure all facilities/utilities/equipment qualification, computerized system, process validation, cleaning validation, MSA are implemented comply with GMP requirements and headquarter policies.

建立确认和验证管理程序,确保所有设施/公用系统/设备的确认、自动化系统、工艺验证、清洁验证、方法验证满足GMP的要求和总部要求。

Organize the qualification and validation implementation and supervision the qualification and validation activities. Responsible for Validation resources management.

组织确认和验证的执行,监控确认和验证的活动。负责验证资源管理。

Support for change control process for evaluating of qualification and validation status.

在变更控制程序中提供确认和验证评估支持。

Review process FMEA as necessary.

必要时审核过程FMEA。

Establish and maintain calibration program with compliance to related regulation and equipment/instrument user requirement.

负责执行和维护校验规程,确保符合相关法规要求和设备/仪器要求。

Involve in set-up and maintenance quality system.

参与质量体系的建立和维护。

Be engaged with design control process to develop process validation strategy.

参与设计控制过程,制定过程验证策略。

Review and approve validation deviation/discrepancy as required.

审核批准验证偏差。

EHS compliance in the responsible area.

负责区域的EHS合规。

Other superior assigned work.

上级指派其它的工作。

SKILLS AND ABILITIES (技能)

Bachelor degree with major for bio, pharma engineering relevant, or production mechanism/electronic.

本科或以上学历毕业,生物工程,制药工程相关专业。

At least 3 years relevant work experience of validation experience in medical devices or drug companies

至少3年以上医疗器械或药品企业验证的相关工作经验

Be familiar with relevant regulation requirements for medical devices, medical devices GMP requirements; medical device GMP/ISO 13485 requirements

熟悉国家有关的医疗器械的法规、熟悉医疗器械GMP要求、熟悉医疗器械GMP/ISO 13485要求。

team player with well communicative and cooperative,

具有良好沟通和协作能力的团队成员

Knowledge of Six Sigma for Manufacturing, Knowledge of analytical and statistical tools

六西格玛知识和分析和统计工具知识 Fluent in listening and speaking in English and Chinese

中英文听说读写流利;

Primary Work Location

CHN Suzhou - Plant 1

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

DirectEmployers