
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 willbe responsible forproviding 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 rightfirst timeexecution, and improve operational efficiency. The OA will alsoassistthe operations team in theday to daymanagement 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, authorcorrectiveand 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 validated state;identifyand escalate any drift from validated parameters before batch release is at risk.
Reinforce GMP and Good Documentation Practice standards through active floor presence and team coaching.
Drive Continuous Improvement in Operations
Collect, analyse, and act on metrics (cycle time, yield, OEE, cost per batch) via MSOE; own at least two improvement metric trends per quarter.
Apply Lean methodologies — value stream mapping, kaizen, standard work — toeliminatenon-value-added steps in operations.
Support batch record review and product release activities, escalating technical holds with documented justification.
Serve as the technical point of contact during shift for equipment and process troubleshooting.
Represent and Connect
Engage with a cross-functional team — finding out what is coming, engaging with others, and ensuring operational requirements are integrated into project and change activity before decisions are made.
Act as the voice of the process team in capital project reviews, functional meetings, and cross-site benchmarking conversations.
Step into the Supervisor or Manager role when those positions are absent,maintainingcontinuity across all ongoing commitments.
Connect with equivalent roles at other Lilly sites to import best practices and share improvements.
Support 24/7 Manufacturing Operations
Be available for on-call duties to support unplanned events, emergency response, and critical production activities outside normal hours.
Provide leadership on shift when Supervisors are absent, ensuring the production floor runs safely and to schedule.
Capital Projects
Represent Production in local and major capital project teams: contribute operational requirements, review designs for GMP impact, andvalidatenew equipment before handover.
Business Title: Operations Associate -MFG-Production 2
Basic Requirements
Education
Bachelor’s degree or higher in Chemistry, Biology, Pharmacy, Chemical Engineering, or a closely related science discipline.
Manufacturing experience
Minimum 2 years on a GMP production floor or in a direct manufacturing support function (pharmaceutical, chemical, FMCG, cosmetics, or food).
GMP knowledge
Able to author a deviation report and change control independently,demonstratingworking knowledge of GMP regulations.
Problem-solving
Demonstrated use of structured root cause analysis tools (5-Why, Ishikawa, FMEA). Be prepared toprovidea specific example at interview.
Languages
Japanese: native / C2. English: independent user sufficient to read SOPs, write investigation summaries, andparticipatein global calls (B2 / intermediate).
Availability
Able to support on-call duties and 24/7 operational requirements as rostered.
Additional Requirements / Information
Leadership Development
This is explicitly a leadership skills development role. The Operations Associate interacts daily with QA, Engineering, Supply Chain, and cross-site networks. Lilly invests in people whodemonstratesafety and quality leadership on the floor; strong performers here have progressed into Process Team Leader and Manager tracks at Kobe HQ, Tokyo, and international sites.
Valued Experience
Change management or quality management system experience (Trackwiseor 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 systemproficiency
Prior experience leading cross-functional improvement projects.
Location & Working Arrangements
NishijinManufacturing Site, Kobe. Hybrid working applies to non-floor activities in line with site policy. Commute limit: 90 km and 90 minutes by public transport from home station; company-leased housing is available forrelocatingcandidates. As part of career development, future scope may include Kobe HQ, Tokyo office, or international site assignments.
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