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.
Responsibilities:
During the project phase, the Operations Manager (OM) will support commissioning, qualification, and validation of the Device Assembly and Packaging (DAP) areas as well as lead / assist in operations readiness programs (e.g. Material procurement and definition, training programs, process excellence, continuous improvement, and capacity planning). The person in this role will be the technical subject matter expert and will be involved in hiring and training personnel. Once the facility is turned over to operations, the OM role is responsible for daily performance management and support of the process teams within DAP. This individual must ensure cross functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the area.
Key Objectives/Deliverables:
Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
Comfortable with exercising and encouraging "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) functional 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 which includes consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, product flows throughout the facility
Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), 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.
Basic Qualifications:
Bachelor's degree in a STEM or pharmaceutical related field of study 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
Additional Skills/Preferences:
Working within 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 QualityDocs, Kneat)
Additional Information
Ability to wear safety equipment (glasses, shoes, gloves, etc.)
Ability to work a minimum of 8 hours per day (schedule starts at 5:45pm) with overtime as required to meet key objectives. NOTE: 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 in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$99,000 - $160,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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