TS/MS Engineer - SA (BB-BBE30)
Found in: Neuvoo CN
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 39,000 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.
TS/MS Engineer - SA
作为SA & Validation Joint角色，同时支持SA和Validation相关的工作：
Prepare, review, approve and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, procedures, PFDs, and VMPs.
Use of risk-based approaches to evaluate existing parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination， including but not limited to:
识别无菌工艺、无菌干预及相关管理，在无菌工艺方面和从风险角度评估来评估他们的可接受性;Identification of aseptic manipulations and interventions and associated controls in parenteral processes and use of risk-based approaches to evaluate their acceptability;
Execution of risk-based approaches to identify areas of highest risk in support of sampling location selection in Environmental Monitoring Performance Qualification protocols and eventual identification of routine EM sampling sites；
Leads site aseptic checks self-inspection program including sharing of observations and recommendations；
Leads or provides consultation for investigation of sterility assurance related events and non-conformances.
Develop/maintain site programs for training and qualification；
Develop Validation Strategy;
Initiate related validation protocols and reports
Leads or provides consultation for investigation of Cleaning and Sterilization related events and non-conformances.
Perform process monitoring for cleaning and sterilization process, ensure the process is within validated status；
Support CI projects.
Accept delegation from supervisor.
• 熟悉GMP 管理规范。
Familiar with GMP knowledge.
Strong document management and project management skills
Strong operation skills
Strong communication and partnering skills.
calendar_today5 minutes ago