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Job Requisition R-77246 <製造本部>オペレーションアソシエイト Operations Associate (OA)/担当・担当課長・課長 /西神工場

Japan, Seishin laboratoriesPosted 1 weeks ago
Full-timeonsite

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 validated state; identify and 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 — to eliminate non-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, maintaining continuity 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, and validate new 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, demonstrating working knowledge of GMP regulations. 

Problem-solving 

Demonstrated use of structured root cause analysis tools (5-Why, Ishikawa, FMEA). Be prepared to provide a specific example at interview. 

Languages 

Japanese: native / C2. English: independent user sufficient to read SOPs, write investigation summaries, and participate in 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 who demonstrate safety 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 (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. 

 

Location & Working Arrangements 

Nishijin Manufacturing 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 for relocating candidates. As part of career development, future scope may include Kobe HQ, Tokyo office, or international site assignments. 

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Job Requisition R-77246 <製造本部>オペレーションアソシエイト Operations Associate (OA)/担当・担当課長・課長 /西神工場 at Lilly | Renata