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Sr. Quality Engineer

Employer
Eli Lilly and Company
Location
Branchburg, New Jersey
Start date
Feb 5, 2024

View more

Discipline
Engineering, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

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.

Responsibilities:

  • Independently works within the Lilly Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE), resolves key technical/quality problems and drives solutions that impact the site.
  • Leads medium-scale projects or programs with moderate risk and/or complexity.  
  • Provides assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution.
  •  Assists with implementation of quality improvement plans.  
  • Provides QA presence in areas of responsibility (Facilities, Utilities, Maintenance, and Engineering (FUME)) by conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between manufacturing facilities.  
  • Prepares cross-functional partners for Regulatory Inspections.
  •  Provides assistance, where necessary, during regulatory/partner inspections.
  •  Ensures compliance deviations associated with Lilly Branchburg Manufacturing Facilities are adequately addressed and completed on schedule.


Key Objectives/Deliverables:

  • Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. 
  • Recommend CAPAs and ensure CAPAs implemented are effective. Review and approve respective development and validation documentation.
  • Evaluate change controls and associated risk assessments. Perform training within group or throughout organization as needed. Write/escalate Notifications to Management, as applicable.
  • Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metrics.
  • Assist in creating quality metrics. Keep Quality management informed of compliance issues. Perform periodic walk-throughs of facilities.
  • Assist in activities associated with technology transfers to and from Lilly Branchburg facilities, as applicable.
  • Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Facilities, Maintenance, Engineering, and Validation issues. 
  • Ensure compliance with applicable regulatory guidelines and GxP computer systems to global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc. as applicable).
  • Perform review of regulatory submissions as necessary.
  • Perform the compliance and risk evaluation of respective systems and departments.
  • Participate in internal audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable.
  • Identify and lead a process improvement projects that impact systems used in a specific functional area.
  • Serve as core member on Process Team(s), a cross functional group charged with making medicine, continuous improvement, and site support in accordance with Manufacturing Standards of Operational Excellence.
  • Serve as key Quality liaison between disposition and compliance by supporting lot release through ensuring timeliness resolve of compliance issues, as applicable.
  • Perform Analysis/Data Audit Trail Reviews.

Basic Qualifications/Requirements:

  • BA/BS degree in the sciences (engineering preferred, typically Chemical or Mechanical Engineering).
  • Requires 1-3 years experience in the Biopharmaceutical industry.
  • Previous technical experience in biotechnology manufacturing processes (large scale cell culture, purification processes, validation) and/or computer systems (i.e. GMARS, TrackWise, Veeva, Kneat, etc.), utilities (i.e. HVAC), and/or purified water systems.

Additional Skills/Preferences:

  • Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
  • Must have experience in developing, reviewing and/or approving the following types of development/validation documents: Validation Plans, User/Functional Requirement Specifications, IQ/OQ/PQ Protocol and Reports, Requirements Traceability Matrix, and Validation Summary Reports.
  • Must possess a conceptual understanding of all Quality functions and business areas.
  • Must possess depth and/or breadth of expertise within area of responsibility.
  • Must have the ability to function in a fast-paced environment and communicate effectively with management.
  • Must be able to work in a cross-functional environment.
  • Must have demonstrate ability to work independently.
  • Must be proficient in Microsoft applications.

Other Information:

Travel required, approximately 10%. Lifting not required. Required to be on call. Shift work may apply.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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