The principal process engineer - Filling plays a critical role as a technical leader and Subject Matter Expert in sterilization, aseptic filling, sealing and handling of sterile drug product to ensure manufacturing processes operate safely, efficiently and in compliance with regulatory standards.
Process Ownership and Equipment Reliability
- Use data to track performance and guide decisions.
- Utilize optimization resources and tools for process analysis and process improvement studies.
- Ensure systems remain in a qualified state and are appropriate for use.
- Ensure maintenance and calibration activities are established and periodically reviewed for trends – generate action plans for improvements, if needed.
- Ensure maintenance and calibration activities are established and periodically reviewed
- Apply statistical thinking and methods to understand process variability and capability, and establish/drive improvements, accordingly.
Technical Leadership
- Assist with and review documents related to key learning points, technical analyses, and investigations of incidents.
- Guide engineers in process expertise, problem-solving, critical thinking, project management, design and excellence in execution. Review and approve documentation/decisions requiring “responsible” engineer level of authority.
- Lead or participate in root cause analysis and countermeasure development and implementation of major safety, quality, or throughput incident investigations. Performs review of incident documentation for technical accuracy.
- Identify process bottlenecks and assist in prioritization of opportunities with respect to overall business objectives.
Regulatory and Audit Readiness
- Act as a key contact during audits (quality, HSE), ensuring adherence to regulatory requirements and site inspection readiness.
Project Leadership
- Develop project scopes for both short- and long-term capital projects, serving as user representative or project manager when needed.
- Sponsor and manage technology transfers, and improvement initiatives from concept through execution.
Technical Performance and Continuous Improvement
- Lead or assist with root cause analysis and countermeasure implementation for major safety, quality, or throughput incidents. Review incident documentation for technical accuracy.
- Support development and technical analysis for long term large-scale initiatives such as productivity improvements, GMP remediation, and safety risk mitigation.
- Review and track key process engineering metrics.
Mentorship and Development
- Coach junior engineers, promote standardization of technical procedures, and foster alignment with global engineering principles.
- Support development of training and training material for cross-functional teams including operations, QA, MSAT
Requirements (Education, Experience, Training):
- Bachelor’s degree in engineering
- 8+ years senior engineering experience in a parenteral manufacturing site
- 5+ years of aseptic filling operation experience
- Solid understanding of basic requirements of regulatory agencies
- Product Tech transfer experience
- Equipment trouble shooting experience
- Previous facility or area start up experience
- Prior experience working effectively with a cross functional group including network and/or global functions
- Excellent interpersonal, written, and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Ability to handle multiple competing priorities
Preferred attributes but not required:
- Previous experience for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- Previous experience with highly automated equipment
- Previous experience with Vials/PFS isolators
- Previous equipment qualification and process validation experience
- Previous experience with Manufacturing Execution Systems and electronic batch release.
- Previous experience with CMMS systems
- Previous experience with deviation and change management systems including Trackwise
Additional Information:
- Day Shift, possible after-hour support
- Project Delivery and/or Plant Shutdown may coincide with company holidays.
- Occasional travel may be required for training, conferences, capital projects, etc.
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). 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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