Lilly Sr. TS/MS Engineer / Associate TS/MS Consultant, CEM 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 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.
This position is responsible for providing technical and manufacturing expertise to support external partners in China with a good partnership maintained to assure patients have safe and efficacious drug products.
As SME, provide technical support to Lilly external partners on Engineer & Process activities (focus on drug substance & drug product process and operation related)，ensure Lilly external partners’ process meet intended use and remains in control and capable, equipment and process are maintained in qualified status in lifecycle, and proper maintenance procedure are prepared and well followed.
Partnering with other disciplines at the external manufacturing, serve as regional process engineering expert in the field of aseptic processing and Parenteral technologies (if applicable);
Support Lilly external partners with new product launching and commercial products change control to current process, assisting them in the design, installation, testing and release of equipment and new facility if required;
Provide expertise on Requirement and implementation strategy for equipment qualification and process validation in accordance with applicable standard;
Periodic visit to Lilly external partners site and follows the progress of the agreed action implementation plan, and working with them on planned changes and deviation investigation;
Assist Lilly external partners with technical evaluations, master planning, technology assessments, and specific problem resolution if required;
Attend routing meetings with Lilly external partners and CEM;
Support Lilly external partners to establish consistent monitoring program on process equipment to enable variability reduction, trends identification and short-term action plans;
Work with external partners and vendors on technology development including experimental design and pilot scale work (if applicable);
Support Lilly external partners in Applying statistical methods and technical analysis to understand process variability and equipment capability, and drive continuous improvement of efficiency, productivity, quality, GMP remediation and safety risk mitigation;
Consult Lilly external partners on training modules for their technical resources and help in the assessment of skill/capability needed and available if requested by Partner;
Evaluate the Equipment situation of the Lilly external partners and inform CEM Director the concern and suggested solution once any issue happened. Participate in equipment and material supplier audit if needed;
Support Lilly external partners in preparation of regulatory audits, support regulatory function in product registration;
Establish and maintain working relationship with global Lilly Manufacturing Science;
Develop the network for technical and scientific communication with internal and external partners of Suzhou site;
Organize technical sharing forums and launch knowledge sharing sessions, participate in internal and external activities (Knowledge share, forum, etc.).
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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!