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.

Job Overview

Provides technical support to achieve the reliable and compliant manufacture of bulk drug substance to predetermined global quality standards via a detailed set of manufacturing instructions and procedures. The candidate will serve as an expert of Contamination Control Strategy.

The candidate will be responsible for:

• Definition and implementation of the routine environment monitoring plan and ensure that such plan is aligned with the Contamination Control Strategy (CCS)and thus the process remains in control and capable.
• Provide technical support to operational staff in terms of Environmental Monitoring (EM), Sanitization, CCS and Cleaning programs.
• Primary responsible for proactively detecting any CCS related data variability and identifying/implementing actions as response to it.
• Contributing to the improvement agenda.
• Performing periodic evaluations for Environmental Monitoring and generating reports to analyze system performance.
• Technical documentation of the CCS program in official sources such as: Process Flow Diagrams (PFDs), Quality Risk Assessments, manufacturing instructions, SOP’s and technical reports.
• Participate in the design and execution of Process, Cleaning, Bioburden Control Strategies and Validation exercises as needed. Ensure CCS process is maintained through the support and oversight of floor operations, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV) and Annual Product Reviews (APR).
• Carry out investigations, identify CAPA plans and present them to deviation board as applicable.
• Own change controls implementation, which is expected to be completed in an effective and timely manner.
• Maintain an effective collaboration with secondary loop personnel, TS/MS laboratory, other functions, and other Lilly manufacturing sites to identify best practices for replication.
• Ensure data integrity and verification procedures are followed. Provide technical support on cleaning processes for new product introduction.

Basic Requirements

• Bachelor’s degree in scientific disciplines such as Molecular Biology or Microbiology with 3 to 5 years of experience in pharmaceutical manufacturing and/or in a CCS program is required.
• Master or PhD degree in scientific disciplines such as Molecular Biology or Microbiology with 1-3 years of experience in pharmaceutical manufacturing and/or in a CCS program.
• Candidate should demonstrate a strong scientific and technical knowledge in microbiology, and statistical data analysis, technical writing.
• Knowledge of cGMPs.
• Strong technical writing and presentation skills.
• Proficiency in process data analysis using statistical tools.
• Excellent interpersonal skills that foster engagement and teamwork in a cross-functional environment.
• Fully bilingual (English and Spanish).
• Team-oriented with strong collaboration skills.
• Ability to influence and exercise sound judgment.
• Demonstrated leadership capabilities.
• Excellent oral and written communication skills.
• Ability to manage multiple assignments in a dynamic environment.
• Availability to support 24/7 operations.
• Relevant industrial experience in Chemical Engineering, development or Quality in Pharmaceutical or Protein Manufacturing Operations is desirable.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

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), en Able (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

$52,500 - $154,000

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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