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Manager-Process Engineer

Branchburg Township, New Jersey

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Req ID 57892BR Title Manager-Process Engineer City Branchburg State / Province New Jersey Country United States

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 39,000 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.

Responsibilities :

This position is responsible for establishing and maintaining systems to ensure the reliable operation, maintenance and qualified state of process equipment, through management of a team of process engineers.  Ensures that the process equipment is in control, compliant and capable of meeting plant production needs, while also driving continuous improvement efforts. This position is responsible for serving as subject matter expert in one or more disciplines, and also providing technical and leadership guidance to engineer team, while also understanding the business impact and drivers outside of their own business area.  This position requires contribution to development of technical plans for Process engineering Front Line team members with a horizon of up to one year.

Manage Process Engineering support for Clinical and Commercial Manufacturing operations: 

  • Manage team of process engineers providing Front Line process engineering support. 
  • Ensure appropriate technical support for all existing manufacturing processes including Bioreactors, chromatography, TFF, Media/Buffer prep, CIP, etc.
  • Makes decisions guided by engineering standards and policies, procedures and business plan that impact the ability of the Process Engineers to meet performance objectives.
  • Provide Functional Leadership to Process Team engineering representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
  • 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 capability
  • Ensure continuous improvement mindset for process and operational improvements
  • Apply statistical thinking and methods to understand process variability and capability and drive improvements.
  • Support regulatory inspections
  • Provide oversight to process equipment to ensure clear understanding of equipment flow, process flow and critical process requirements across all process steps on site.
  • Establish control systems to monitor, trend and verify equipment performance and downtime.  Identify and Optimize unit operation cycle time, loading, yield performance, etc.
  • Support or lead troubleshooting efforts to resolve equipment and operational problems, and ensure formal problem solving techniques are appropriately utilized.
  • Lead the process safety agenda for the process equipment
  • Understand and ensure compliance with engineering standards, and environment health & safety requirements.
  • Develop, review and approve technical documentations such as SOPs, Batch Records, Investigations, etc.
  • Present and attend various Governance teams to represent process engineering
  • Support commissioning and qualification activities

Leadership

  • This position involves direct management of Front-Line process engineering team members
  • Provide leadership, training, development and support of process engineering team members.
  • Engage and promote use of internal and external networks to help deliver sound technical decisions.  
  • Promote use of first principals with engineering staff, and drive engineering solutions for problems.
  • Monitor and ensure compliance with training requirements

Basic Qualifications :

  • Bachelor of Science, Engineering
  • 7-10+ years industrial experience in a cGMP environment
  • Knowledge of / experience with several biopharmaceutical processes and equipment, such as bioreactors, centrifuges, TFF and chromatography systems, media/buffer prep and CIP/SIP.

Additional Skills/Preferences :

  • Strong leadership skills
  •  Strong written and oral communication skills
  • Aggressive, take-charge, self-directed personality, with ability to work independently, self-sufficiently and pro-actively in the performance of work duties.
  • Ability to resolve conflict, and promote good decision making among team members
  • 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 57892BR.

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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