Principal Process Engineer

BioSpace; Indianapolis (IN); On-site; USD 64,500 - 167,200; Full time

Benefits offered by this job

401(k) and pension

Comprehensive medical benefits

Flexible benefits

Job summary

A global healthcare leader in Indianapolis seeks a Principal Engineer for their Device and Packaging Manufacturing division. This pivotal role includes providing technical oversight, developing automated assembly processes, and ensuring compliance with GMP standards. Candidates should possess a Bachelor's degree and 5+ years in pharmaceutical manufacturing. The position offers a comprehensive benefits package with a competitive salary range of $64,500 – $167,200 per year.

Qualifications

• 5+ years’ experience in pharmaceutical manufacturing or regulated industry.
• Deep knowledge of GMPs, risk management, and commissioning practices.

Responsibilities

• Provide technical oversight for automated assembly processes.
• Drive improvement opportunities and ensure regulatory compliance.
• Mentor and create a safety-first quality culture.

Skills

Pharmaceutical manufacturing experience

Leadership and communication

Analytical and problem-solving abilities

Knowledge of GMPs

Education

Bachelor's Degree in Engineering, Science or related field

Job description

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.

Position Brand Description

Join us in a dynamic role where you will be a pivotal force in our Device and Packaging Manufacturing division. As a Principal Engineer, you will provide technical oversight and work on the development and optimization of automated assembly processes. You will be accountable for technical aspects of quality direct impact systems and critical components used in production, testing, packaging, labeling, and storage of manufactured products to maintain the reliable supply for products across the site.

Key Objectives And Deliverables

Technical Subject Matter Expert (SME) Oversight

• Demonstrate strong ownership for the equipment and packaging area you support by being flexible, proactive and involved.
• Serve as a responsible engineer for site process lines, possessing deep knowledge of equipment and unit operation design characteristics on assembly and packaging lines.
• Ensure the equipment is maintained in its validated state (AQM).
• Approve the scope of qualifications and re‑qualification monitoring activities.
• Review and/or approve significant changes, maintenance, and other interventions for potential adverse impact on safety or quality integrity.

Innovation And Problem‑Solving

• Provide equipment and processing support for production issue resolution with data analysis and first‑principles applications, ensuring reliable solutions, safe execution, and regulatory compliance.
• Identify and drive improvement opportunities.
• Support complex site investigations of key safety and production issues and events, working on CAPA plans to prevent recurrence.

Regulatory Compliance

• Ensure adherence to cGMP standards, OSHA regulations, and environmental sustainability goals.
• Support site inspection readiness and execution, interacting directly with Regulatory Agencies during inspections.

Process Optimization

• Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools.
• Use first principles and theoretical knowledge to define scientific approaches to support technical improvements, improving process robustness, reducing variability, and increasing operational uptime.

Cross‑Functional Collaboration

• Foster knowledge sharing and education within the team and with key partners to drive alignment, share best practices, and meet manufacturing goals.
• Collaboratively integrate disciplines such as quality, technical services, and operations on projects and performance improvements.

Mentorship

• Mentor and coach technical resources on scientific approach, technology, and business behaviors.
• Create a safe and encouraging environment for colleagues to share ideas, contribute, and thrive.

Safety And Quality Culture

• Lead by example in building a culture of safety first and quality always within the organization.
• Author, review, and/or approve GMP documentation including procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols, and summary reports.

Minimum Qualifications

• Bachelor's Degree in Engineering, Science or related field.
• 5+ years’ experience in pharmaceutical manufacturing or regulated industry.
• In‑depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices.

Additional Preferences And Information

• Prior experience in packaging and/or dry/wet device assembling operations.
• Experience with asset design, delivery, and startup.
• Strong technical leadership and communication skills, influencing cross‑disciplinary teams.
• Excellent interpersonal and presentation skills.
• Ability to work independently and in teams, partnering across disciplines.
• Strong analytical and problem‑solving abilities.
• Variable travel 0‑50% as required.

Compensation range: $64,500 – $167,200 per year based on education, experience, skills, and geographic location. Full‑time employees are eligible for a company bonus and a comprehensive benefits program including 401(k), pension, vacation, medical, dental, vision, prescription drug coverage, flexible benefits, life insurance, and well‑being benefits.

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.

Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for assistance.