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.
Provides technical oversight of the process equipment and is responsible for ensuring that the equipment remains in a qualified state in order to support the manufacture of bulk drug substance.
Key Objectives/Deliverables:Process and Equipment Support:
- Equipment owner integrating process, process safety, environmental requirements and equipment knowledge.
- Monitor established equipment systems for process indicators to identify potential issues affecting production.
- Investigate and resolve equipment performance issues.
- Technical expert/support for installation and maintenance of process equipment and equipment improvements.
- Develop training / tools for operations to transfer knowledge of equipment capabilities and operational techniques to operations and maintenance.
Improving the Business or Process:
- Identify/Implement improvement projects for capacity, product quality, raw material cost, emissions/waste loads, process variability and process safety.
- Perform and summarize improvement opportunities in technical reports
- Understand process/unit capacity constraints.
- Lead or participate in equipment/process qualification activities (including commissioning activities of new equipment or areas).
Health, Safety and Environmental Management:
- May provide the technical leadership and problem solving skills for Health, Safety and Environmental incident investigations.
- Perform compliance related technical tasks such as emissions calculations, equipment evaluation, and application of material balances for env needs.
- Lead and/or participate in process hazard reviews and other process safety activities, main resource for process safety issues on supported processes.
Adherence to Business Systems:
- Manage the implementation of countermeasures arising from deviations, spills, and safety related events.
- Manage the implementation of recommendations from PHRs and other audit findings.
- Maintain training compliance.
- Maintain and establish the equipment technical information for the process;
- Equipment procedures, P&IDs, Material of Construction Compatibility Index, Equipment information in PFDs, Aspen models, Material & Energy Balances, Process Safety Information
Basic Requirements:- Bachelor of Science Degree in Engineering
- 2+ years of pharmaceutical manufacturing (or equivalent), preferably in API
Additional Preferences:- Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement.
- Ability to function in a team environment
- Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
- Available on call to address processing emergencies over the phone and at times return to the plant during off-hours.
- Experience with Change Management, Deviation Management, Periodic Reviews, Commissioning and Qualification, Routine Data Monitoring
- Ability to apply statistical thinking concepts to the analysis of manufacturing processes
- Visualize an operation/process and reflect it in a model
- Root cause analysis and the problem solving
- Process Hazard Identification/ Mitigation Skills
- Strong Computer skills in a variety of software packages (Batch Plus, JMP, Visio, PI Data Historian, MS Project, Excel)
- Experience with normal processing equipment/unit operations
Other Information: - This position serves an extended coverage night shift position: 3pm to 3am, 3 days on with 3 days off. Shift premium is included for this position. Situations may arise where off-schedule work, both on-site and off-site, will be required.
- This position works weekends and holidays per shift schedule.
- This position requires little to no travel.
- Tasks require entering manufacturing and laboratory areas, which require wearing appropriate PPE and the ability to access plant operating equipment including climbing of stairs and ladders.
- This position requires 24/7 availability via cell phone.
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 ( 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
$66,000 - $149,600
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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