Operations Manager - Night Shift

Overview

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 worldwide 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 put people first and strive to make life better for people globally.

During the project phase, the Operations Manager (OM) will support commissioning, qualification, and validation of the Device Assembly and Packaging (DAP) areas and lead/assist in operations readiness programs (e.g., material procurement and definition, training programs, process excellence, continuous improvement, and capacity planning). The OM will serve as the technical subject matter expert and will be involved in hiring and training personnel.

Once the facility is turned over to operations, the OM is responsible for daily performance management and support of the process teams within DAP. This role requires cross-functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the area.

• Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Encourage and exercise Stop Work Authority for all employees if there is a perceived unsafe or product-impacting situation.
• Lead/conduct area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) groups.
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
• Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
• Lead and facilitate operations readiness activities and programs for the operations portion of the business, including consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, product flows throughout the facility.
• Participate in developing and implementing strategies focused on Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area.
• Develop, monitor, and propose solutions to improve or meet key performance indicators (KPI) for the area.
• Lead area tours to support business reviews, regulatory audits, or network collaboration.

• Bachelor's degree in a STEM or pharmaceutical-related field with 5+ years in Manufacturing Operations.
• At least 4 years of supervisory or manager experience.
• Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA, or other similar groups.
• Excellence in electronic, written, and oral communication skills.
• Strong technical aptitude as demonstrated through previous work or educational accomplishments.

• Experience with in or directly supporting pharmaceutical, food, packaging, or applicable manufacturing departments.
• Highly automated equipment (inspection, filling, device assembly, packaging, etc.).
• Advanced computational capabilities (e.g., Data Analysis, Pareto and Control charting, Trending and computing with multiple variables).
• Technical writing such as creation of standard operating procedures, work instructions, and training documentation.
• Facility, Equipment, Systems Start-up.
• Equipment design, qualification, and process validation.
• Manufacturing Execution Systems and electronic batch release.
• Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
• Continuous improvement methodologies and mindset – lean, six sigma, etc.
• Documentation, deviation and change management systems (e.g., Trackwise, Veeva Quality Docs, Kneat).

• Ability to wear safety equipment (glasses, shoes, gloves, etc.).
• Ability to work a minimum of 8 hours per day (schedule may start at 5:45pm) with overtime as required to meet key objectives. Times and days may change depending on business needs.
• Ability to work and gown in a cleanroom (Grade C, ISO
  8) environment.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described. For GMP purposes, update the description for significant changes. Consult with your supervisor regarding actual job responsibilities and related duties.

Lilly is dedicated to…