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Principal Engineer - Process

Principal Engineer - Process

BioSpaceIndianapolis, IN, US
16 days ago
Job type
  • Full-time
Job description

Job Details

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.

Organization Overview :

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description :

Principal Engineer - Secondary Loop Process Engineer will be responsible for ensuring the reliable operation and qualified state of vision inspection equipment within a GMP-regulated pharmaceutical manufacturing environment. The Principal Engineer is accountable for the technical oversight of equipment and processes critical to safety, quality, and compliance within Lilly's manufacturing operations. This role involves leading the qualification, validation, and optimization of automated visual inspection systems, developing advanced vision configuration recipes, troubleshooting complex equipment issues, and driving continuous improvement initiatives. The engineer will leverage statistical analysis and formal problem-solving methodologies to enhance equipment performance and ensure compliance with regulatory standards. The position focuses on troubleshooting, process improvements, and technical investigations. Additionally, the role requires cross-functional collaboration with process teams, mentoring of junior engineers, and influencing strategic technical decisions to drive operational excellence.

Key Objectives / Deliverables / Responsibilities :

  • Provide secondary loop engineering ownership by supporting vision inspection processes across multiple assets; serve as primary loop backfill during vacations and staffing gaps.
  • Lead and execute change initiatives from end-to-end, including creation of change controls, implementation plans, qualification documentation (C / Q), and project execution aligned to GMP and site procedures.
  • Own complex equipment investigations and deviations, applying structured problem-solving tools (e.g., RCA, 5 Whys, FMEA) to drive timely resolution and sustained improvements.
  • Champion visual inspection excellence through vision configuration development, optimization, and performance monitoring to ensure robust defect detection and recipe validation.
  • Drive qualification and validation activities, including PVP development, test case pre-approvals, post-approvals, and coordination of qualification resources to meet schedule and compliance standards.
  • Lead shutdown planning and execution for inspection assets, ensuring scope alignment, coordination of tasks, and full engagement during execution to minimize downtime and ensure flawless startup.
  • Support cross-functional collaboration through active participation in process team meetings, technical forums, and improvement projects that enhance inspection reliability, throughput, and quality.
  • Coach and mentor engineers and technicians, building site capability in vision inspection, qualification best practices, and automated system troubleshooting.
  • Ensure adherence to regulatory and compliance expectations by maintaining validated state of equipment, updating all relevant documents (e.g., QRS, PVPRs, C / Q docs), and driving inspection readiness.
  • Monitor and improve equipment performance through use of statistical analysis, OEE tracking, OSI PI data, and technical metrics to identify trends and implement improvements.

Basic Requirements

  • Bachelors Degree in Engineering.
  • 5 years of experience in process engineering, vision engineering, or equivalent experience.

    • Additional Preferences

  • Demonstrated ability to work in a safe manner to ensure the safety of self and others.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  • Adequate interpersonal and communications skills to be able to work effectively in a cross-functional, collaborative, team-based environment.
  • Strong computer skills in a variety of software packages (Excel, JMP, etc.).
  • Demonstrated ability to work independently with strong organizational skills and attention to detail and ability to adapt to rapidly changing priorities
  • Engineering and / or maintenance experience.
  • Demonstrated expertise in troubleshooting automated inspection systems, developing vision recipes, and optimizing defect detection performance.
  • Experience working within a Good Manufacturing Practices (GMP)-regulated setting, ensuring compliance with validation, qualification, and regulatory requirements.
  • Strong technical problem-solving skills, with experience utilizing Root Cause Analysis (RCA) and data-driven decision-making tools.
  • Experience leading equipment qualifications, process validations (IQ / OQ / PQ), and performance monitoring to maintain a validated state.
  • Proven ability to work cross-functionally with manufacturing, quality, and engineering teams to drive process improvements.
  • Excellent communication and leadership skills, with experience mentoring and training technical teams.
  • Previous experience as a process engineer within the Pharmaceutical Industry.
  • Strong equipment / process troubleshooting skills.
  • Ability to apply scientific and / or statistical thinking concepts to the analysis of manufacturing problems.
  • Experience in utilizing root cause analysis techniques for the systematic solving of problems.
  • Knowledge of Parenteral equipment and manufacturing operations, specifically vision systems and highly automated systems.
  • Experience in M&Q GMP processes, such as Change Management and Event Management.

    • Other Information

  • 8-hour dayshift
  • Must be willing to work extended hours during peak periods
  • Must be willing to respond to off-hour emergencies, when necessary.
  • Occasional travel may be required for training, conferences, capital projects, etc.

    • 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

    64,500 - $167,200

    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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