Sr. Process Engineer

100 Eli Lilly and Company; United States; On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k) retirement plan

Pension

Vacation benefits

Medical, dental, vision coverage

Flexible spending accounts

Life insurance

Paid time off and leaves

Well-being programs

Job summary

Lilly is seeking an engineer for the Process Engineering group to support GMP manufacturing of API development and clinical trial materials. You will interface between development and operations, troubleshoot equipment, and lead qualification activities across transfers and projects.

Responsibilities include monitoring performance, driving continuous improvement, maintaining equipment qualification, and delivering training to operations teams while upholding HSE and Quality standards.

Qualifications

• BS in engineering; chemical/biomedical/mechanical preferred.
• 3+ years in manufacturing GMP operations.
• Authorized to work in the United States full-time; no visa sponsorship.

Responsibilities

• Monitor equipment and process performance to identify risks and optimization opportunities.
• Provide input for technical transfer of new processes from development to manufacturing.
• Lead continuous improvement initiatives related to equipment performance and process capability.
• Maintain knowledge of processes, equipment, facilities, systems, and practices.
• Lead multi-disciplinary projects to define scope, design, and implement goals.
• Act as primary resource for safety issues and investigations related to equipment.
• Ensure equipment remains qualified throughout its lifecycle with proper documentation.
• Lead or support commissioning and qualification activities for assets.
• Provide operational input during capital projects from design to startup.
• Develop training materials to transfer equipment knowledge to operations.

Skills

GMP operations experience

Root cause analysis

Change management

Deviation management

Pharmaceutical experience

Manufacturing experience

Education

Bachelor's degree in engineering

Tools

UNICORN

DeltaV

OSI PI

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters.

Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work- but its work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

This position is an engineering role within the Process Engineering group in the Bioprocess Clinical Trials Manufacturing Facility, supporting the manufacture of bulk drug substance (API). Individuals in this role provide engineering support to the maintenance and operations teams as needed to maintain production of API for development and clinical trial purposes. This role serves as a key interface between development and operations during technology transfer activities and acts as the primary contact for equipment troubleshooting and performance issues.

Key Responsibilities

• Monitor equipment and process performance using defined indicators to proactively identify risks to production and opportunities for optimization.
• Provide engineering and equipment input for technical transfer of new processes from development into the manufacturing area.
• Identify, lead, and implement continuous improvement initiatives related to equipment performance, reliability, and process capability.
• Maintain a comprehensive working knowledge of the manufacturing processes, associated equipment, facilities, computer systems, and operational practices.
• Drive completion of assigned projects by leading multi-disciplinary teams to develop scope, agree to design, and efficiently execute implementation of project goals.
• Serve as the primary resource for safety issues associated with supported processes and equipment.
• Conduct equipment related investigations and lead implementation of associated corrective and preventative actions.
• Ensure equipment remains in a qualified state throughout its lifecycle through appropriate monitoring, maintenance, and documentation.
• Serve as the primary point of contact for the introduction of new consumables or changes to existing consumables.
• Lead or support equipment commissioning and qualification activities for new and existing assets.
• Act as the user representative for capital projects, providing operational and technical input throughout design, construction, and startup.
• Develop and deliver training materials and tools to transfer equipment knowledge and operational practices to operations and maintenance teams.
• Support the development, review, and approval of preventive maintenance procedures and spare part strategies.
• Ensure ongoing compliance with all applicable Health Safety and Environmental (HSE) and Quality requirements.

Minimum Requirements

• Bachelors of science degree in engineering (Chemical Engineering, Biomedical Engineering, or Mechanical Engineering preferred)
• 3+ years of experience working in a manufacturing environment supporting GMP operations
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Skills and Preferences

• Previous experience with Change Management, Deviation Management, Commissioning and Qualification and/or Routine Data Monitoring
• Experience using root cause analysis techniques for the systemic solving of problems.
• Pharmaceutical experience
• Familiarity with industrial computer systems (e.x. UNICORN, DeltaV, OSI PI)

Additional Information

Monday through Friday 8 hour days with flexibility to provide occasional off hours support.

Travel: 0% - 10%

Employee Resource Groups

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Compensation

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is $66,000 - $171,600.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• 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
• 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.

WeAreLilly

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!