Automation Engineer (R3)

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 97,718 - 137,921; Full time

Benefits offered by this job

Company bonus

401(k) participation

Comprehensive benefit program

Well-being benefits

Job summary

Initial Therapeutics, Inc. is seeking an Automation Engineer in Indianapolis, IN. This role focuses on developing and qualifying new components within the Global Serialization solution while ensuring compliance with GMP and CSV standards.

The ideal candidate should have a Bachelor’s degree in Manufacturing Engineering or related fields and at least 2 years of experience with automation and testing on production equipment. A range of benefits, including a comprehensive compensation package, is offered.

Qualifications

• Minimum 2 years of experience with GMP, computer systems validation, and automation for integrating processes.
• Minimum 2 years of hands-on testing on production equipment.
• Minimum 2 years of preparing change controls and SOPs.

Responsibilities

• Develop and qualify new components for Global Serialization solution.
• Design and validate core serialization solution for packaging lines.
• Lead activities to ensure compliance with GMP and CSV standards.

Skills

GMP compliance

Computer systems validation

Testing production equipment

Root cause analysis

Change controls preparation

Project management

Education

Bachelor’s degree in Manufacturing Engineering, Mechatronics Engineering, Computer Science, or related STEM field

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 it’s 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.

We are seeking an Automation Engineer (R3) to develop and qualify new components and functionality within the Global Serialization solution. Design, configure, and validate the global core serialization solution for packaging lines. Lead technical activities for Global Serialization releases to ensure compliance with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) standards; conduct testing, troubleshooting, and maintenance of the MQLC test line; maintain and update validation deliverables and technical documentation in adherence to governing procedures; partner with Tech@Lilly and cross‑functional teams to ensure released functionality aligns with LQPs, GQSs, and the Packaging Control Strategy.

Responsibilities

• Develop and qualify new components and functionality within the Global Serialization solution.
• Design, configure, and validate the global core serialization solution for packaging lines.
• Lead technical activities for Global Serialization releases to ensure compliance with GMP and CSV standards.
• Conduct testing, troubleshooting, and maintenance of the MQLC test line.
• Maintain and update validation deliverables and technical documentation in adherence to governing procedures.
• Partner with Tech@Lilly and cross‑functional teams to ensure released functionality aligns with LQPs, GQSs, and the Packaging Control Strategy.

Qualifications

• Bachelor’s degree in Manufacturing Engineering, Mechatronics Engineering, Computer Science, or a related STEM field.
• Minimum 2 years of experience with GMP, computer systems validation, and automation for integrating manufacturing processes and equipment.
• Minimum 2 years of hands‑on testing on production equipment.
• Minimum 2 years of identifying and resolving manufacturing non‑conformances and performing root cause analysis.
• Minimum 2 years of preparing, reviewing, and revising SOPs, performing failure mode analysis assessments, deviations, protocols, risk assessments, and creating training documentation.
• Minimum 2 years of preparing change controls involving technical and process scope updates.
• Minimum 1 year of connecting computer systems per the S95 architecture.
• Minimum 1 year of managing projects and interacting with equipment vendors to design machines and computer systems per requirements.
• Minimum 1 year of establishing and maintaining the reliable operation and qualified state of manufacturing equipment.
• Up to 25% domestic and international travel.

Job location: Indianapolis, IN.

Compensation

$97,718.00 - $137,921.00 per year. Full‑time employees also eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision and prescription drug benefits, flexible benefits such as health or dependent care flexible spending accounts, life and death insurance, leave of absence benefits, and well‑being benefits including an employee assistance program, fitness benefits, and employee clubs and activities.

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.