Lilly
OperationsAssociate(OA)/担当・担当課長・課長/西神工場
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Operations Associate (OA)/担当・担当課長・課長 /西神工場 at Lilly. Skills: Process management, Cross-functional coordination, Continuous improvement, Quality resolution. Provide leadership within process team.. Manage projects and process improvements.”
What You'll Achieve.
Drive injury reduction; Ensure right first time execution; Improve operational efficiency; Measured in observations completed, actions closed, and initiatives launched; Verify effectiveness of corrective and preventive actions; Escalate any drift from validated parameters before batch release is at risk; Eliminate non-value-added steps in operations; Contribute operational requirements; Review designs for GMP impact; Validate new equipment before handover
Industry & Context.
Structured root cause analysis tools; 5-Why; Ishikawa; FMEA; Root cause investigations; Troubleshooting
On-call availability, Support 24/7 manufacturing operations, On-call duties, 24/7 operational requirements, Shift availability
What They're Looking For.
Must Have
Bachelor’s degree or higher in Chemistry, Biology, Pharmacy, Chemical Engineering, or a closely related science discipline., Minimum 2 years on a GMP production floor or in a direct manufacturing support function (pharmaceutical, chemical, FMCG, cosmetics, or food)., Able to author a deviation report and change control independently, demonstrating working knowledge of GMP regulations., Demonstrated use of structured root cause analysis tools (5-Why, Ishikawa, FMEA)., Japanese: native / C2., English: independent user sufficient to read SOPs, write investigation summaries, and participate in global calls (B2 / intermediate)., Able to support on-call duties and 24/7 operational requirements as rostered.
Nice to Have
Change management or quality management system experience (Trackwise or equivalent)., Lean or Six Sigma certification (Yellow Belt or above)., Experience in pharmaceutical injectables or solid-dose manufacturing., MSOE, SAP, or equivalent manufacturing execution / ERP system proficiency., Prior experience leading cross-functional improvement projects.
What You'll Do.
Provide leadership within process team.
Manage projects and process improvements.
Act as liaison between operations and functional groups.
Drive injury reduction.
Ensure right first time execution.
Improve operational efficiency.
Assist operations team day-to-day.
Serve as acting manager when absent.
Drive injury reduction via B-safe observations.
Close assigned corrective actions.
Participate in safety patrols.
Contribute safety improvement initiative.
Lead root cause investigations.
Define investigation scope.
Conduct structured analysis.
Author corrective and preventive actions.
Own change controls from initiation.
Coordinate impact assessments.
Maintain validated processes.
Identify and escalate drift.
Reinforce GMP standards.
Reinforce Good Documentation Practice.
Apply Lean methodologies.
Eliminate non-value-added steps.
Support batch record review.
Support product release activities.
Escalate technical holds.
Serve as technical point of contact.
Engage with cross-functional team.
Ensure operational requirements integrated.
Act as voice of process team.
Step into Supervisor or Manager role.
Connect with equivalent roles at other sites.
Be available for on-call duties.
Support unplanned events.
Support emergency response.
Support critical production activities.
Provide leadership on shift.
Ensure production floor runs safely.
Ensure production floor runs to schedule.
Represent Production in capital project teams.
Contribute operational requirements.
Review designs for GMP impact.
Validate new equipment before handover.
How You'll Work.
Team & Collaboration
Act as a liaison between operations and multiple functional groups.; Engage with a cross-functional team.; Find out what is coming.; Engage with others.; Ensure operational requirements are integrated into project and change activity.; Act as the voice of the process team in capital project reviews, functional meetings, and cross-site benchmarking conversations.; Connect with equivalent roles at other Lilly sites to import best practices and share improvements.; Represent Production in local and major capital project teams.
Communication Scope
Participate in global calls
Process & Methodology
Managing projects, Process improvements, Capital project teams, Leading cross-functional improvement projects
Full Job 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. The Operations Associate will be responsible for providing leadership within the area’s process team, managing projects and process improvements, acting as a liaison between operations and multiple functional groups to drive injury reduction, ensure right first time execution, and improve operational efficiency. The OA will also assist the operations team in the day to day management of the production floor and serve as acting manager when the role is absent. This is a hands-on, floor-facing role with cross-functional accountability, including on-call availability to support 24/7 manufacturing operations. **Build Safety Culture** * Drive injury reduction by conducting B-safe observations at the frequency set by site targets and closing assigned corrective actions within agreed timelines. * Participate in safety patrols and contribute at least one safety improvement initiative per performance cycle. * Build a culture where safety is a personal commitment — measured in observations completed, actions closed, and initiatives launched, not incidents avoided. **Lead Quality Resolution** * Lead root cause investigations when events occur on the floor: define scope, conduct structured analysis, author corrective and preventive actions, and verify their effectiveness. * Own change controls from initiation through approval, coordinating impact assessments across QA, Engineering, and Regulatory Affairs. * Maintain processes in a validat
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