23 Sep, 2021

Lead Process Engineer

  • Lilly
  • Branchburg, NJ, USA
Process Engineer Biochemicals / Pharmaceuticals

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 35,000 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.

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.

Primary Responsibilities

The Process Engineering Responsible Engineer provides technical leadership and expertise for production operations in the areas of:  Coaching and Mentoring Front Line Process Engineers, Lead/Solve Complex Investigations with Strong Root Cause Analysis Skills, Developing and Sustaining Process Knowledge, Process & Equipment Support, Process Optimization & Continuous Improvement, Equipment Capability & Asset Management, and Adherence to Business Systems.

Coach and Mentor Front-Line Process Engineers

  • Coach and mentor front-line process engineers in aspects of fundamental engineering support including process understanding (both theoretical and practical), problem solving, project management, and engineering design.
  • Relate experiences with troubleshooting bioprocess equipment within area of support, ie Buffer Preparation/Media Preparation, Buffer Hold, Weigh Scales, Single Use Mixers, Washers, Autoclaves, CIP Skids, etc.
  • Ensure product change over requirements are being met, Measurement Uncertainty for Critical Process Parameter assessment, Extractables Leachables assessment, GMP Critical Operational Data Instrumentation
  • Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions.  Ensure operational control strategies are appropriate and implemented.
  • Support and peer review root cause analysis around equipment and operational events, support complex change controls, investigations.  Lead Complex investigations and have strong Root Cause analysis
  • Present and attend various Governance teams as required for technical initiatives. 
  • Promote and peer review documentation of learning points, technical studies, and event investigations.

Develop and Sustain Process Knowledge

  • Identify process knowledge gaps that impact equipment and process capability.
  • Enable the development and/or maintenance of process knowledge infrastructure such as key models, report history, lab models, and literature
  • Utilize optimization resources and tools for process analysis and process improvement studies.
  • Develop and support technical training of operations team members.
  • Support development, review, and tracking of key process engineering metrics.

Process Optimization & Continuous Improvement

  • Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, new product introduction, capacity development, GMP remediation, and safety risk mitigation.
  • Review and identify cost reduction opportunities as well as process capacities and bottlenecks and assist in prioritization of opportunities with respect to overall business objectives.
  • Apply statistical thinking and methods to understand process variability and capability and drive improvements.
  • Perform and promote optimization of unit operation cycle time, loading, and yield performance.
  • Collaborate with key support groups around the development of process knowledge and a common process improvement agenda.

Equipment Capability and Asset Management

  • Provide technical oversight of Asset Qualification Management for Direct Impact systems to ensure constant state of qualification.
  • Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure that equipment/systems are appropriate for the intended purpose.
  • Provide guidance in development of test plans for Commissioning and Qualification packages and associated critical components.
  • Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance.
  • Support scope development for capital projects targeted at both short and long term needs and act as user representative in some cases.
  • Review and approve documentation/decisions requiring "Responsible Engineer" level of authority.
  • Performs all job functions with adherence to company policies, in a cGMP manner, safely and ethically.

Basic Qualifications :

  • Bachelor of Science, Chemical, Mechanical Engineering or related engineering discipline
  • 10+ years industrial experience in a cGMP environment
  • Knowledge of / experience with several biopharmaceutical processes and equipment, such as Buffer/Media Preparation systems, Single Use Mixers, Weigh scales, Autoclaves, Washers, CIP systems.

Additional Skills/Preferences :

  • Strong leadership skills
  • Strong written and oral communication skills
  • Able to accelerate and deliver, curious, and solution driven.  Self-directed personality, with ability to work independently, self-sufficiently, and proactively in the performance of work duties.
  • Experience with various root cause analysis tools/techniques

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-16178.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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