Lilly TS/MS Engineer- SA in Suzhou Manufacturing-苏州, China
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 35,000 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.
Represent/defend site sterility assurance strategies during internal assessments/audits and external regulatory inspections. Participate in self-inspections, aimed at ascertaining specific aspects of sterility assurance.
Participates / coordinates the investigation and resolution of Sterility Assurance issues in operational activities and in revalidation / requalification as in the PQ, APS and PV phase.
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. Evaluate, identify consumable items used in aseptic processes and participates / coordinates investigation of issues associated with their use.
Evaluate the impact of changes in relation to aspects of Sterility assurance and then implements and controls the agreed actions.
Understand the scientific principles required for manufacturing parenteral drug products, including the interactions between equipment, aseptic processes and container closure systems.
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.
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.
Evaluates the performance of people in terms of aseptic handling, performs periodic retraining of personnel with access to the aseptic block, trains people who have to enter the aseptic block for the first time and work in classified areas; as part of the RABS filling process, it participates in the definition of staff retraining strategies during APS
Ensure that an accurate instruction set (batch records and procedures) and PFD describe the process as performed and the control strategy for sterility assurance in the discrete manufacturing steps.
Understand, justify and document the state of validation (process validations and other related validation activities including aseptic process simulation APS) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
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.
Develop, monitor and appropriately react to established statistically based metrics in real-time environment and personnel monitoring to assess potential risk.
Implements the strategies of APS, Filtration Validation, EMPQ, Sanitization, Sterilization, Depyrogenation, Leaks Mngt, Glove Mngt, Gowning, Biological Particle characterization, Cleaning validation (microbiological aspects), validation of sanitizing agents and Container Closure Validation.
- 准备和/或审核与无菌保证相关的EMPQ / PQ / APS / PV / QRM /法规文件
Prepares and / or reviews EMPQ / PQ / APS / PV / QRM / Regulatory documents relating to aspects of Sterility Assurance
Accept delegation from supervisor.
- 参与工艺团队的开发和实施，以积极的方式实施TS / MS目标，并达成业务和质量目标。
Participate in development and implementation of process teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.
- 可能需要在与无菌保证有关的Network Lilly活动中进行合作
May need to collaborate in Network Lilly activities related to Sterility Assurance
Support CI projects.
Adherence to all the safety policies, standards and guidelines.
Understanding of GMPs and applicable internal standards
Technical writing and presentation skills
Good and strong written and oral English communication skills.
Good teamwork and interpersonal skills.
Good computer skills .
Good skills in analytical thinking, multi-tasking, decision-making and problem-solving.
Good skills in leadership, project management, ability to influence and lead projects.
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!