Scientist TSMS -CCS/Cleaning

Eli Lilly and Company • Carolina, PR

2d • $52,500 - $154,000

About The Position

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 requisition Scientist-TSMS CCS Responsibilities: The Scientist-TSMS CCS will provide direct technical support to the cleaning validation program of the fermentation and protein purification manufacturing processes. The candidate will own the Cleaning Control Strategy, including the cleaning parameters, and the historic and potential failure modes associated countermeasures. The candidate will be responsible for the definition and implementation of the routine process monitoring plan and ensure that process monitoring plan is aligned with the Cleaning Control Strategy and thus the process remains in control. The selected candidate will be primary responsible for proactively detecting any change in cleaning data variability and identifying/implementing actions as response to it. She/he will be responsible to drive the cleaning improvement agenda. Translate cleaning process requirements and educating Process Teams and operators; design, review, and deliver Process School(s) at the beginning of each campaign, as applicable. The selected candidate will be responsible for technical documentation of the cleaning program in official sources such as: Process Flow Diagrams (PFDs), Quality Risk Assessments, manufacturing instructions, SOP’s and technical reports. Participates in the design and execution of Process, Cleaning, Bioburden Control Strategies and Validation exercises. Ensure cleaning process remains in a validated state via routine monitoring, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV) and Annual Product Reviews (APR). He/she will be responsible to carry out investigations, identify CAPA plans and present them to deviation board. The candidate will own change controls implementation, which are 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.

Requirements

• Bachelor’s or master's degree in Chemical Engineering ( preferred ), Industrial Engineering or Biochemistry ( Molecular Biology).
• 2-5 years of experience in a regulated pharmaceutical manufacturing and/or in a cleaning validation program is required.
• Knowledge of cGMP’s
• Strong technical writing and presentation skills
• Strong process data analysis using statistical tools
• Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment
• Fully bilingual (English and Spanish)
• Teamwork oriented
• Ability to influence; exercise sound judgment
• Demonstrated leadership skills
• Excellent communication skills, both oral and written.
• Work with multiple assignments at a time and within an environment with distractions.

Nice To Haves

• Demonstrated strong scientific and technical knowledge in microbiology, engineering, fermentation, statistical data analysis, technical writing and project management is desirable.

Responsibilities

• Provide direct technical support to the cleaning validation program of the fermentation and protein purification manufacturing processes.
• Own the Cleaning Control Strategy, including the cleaning parameters, and the historic and potential failure modes associated countermeasures.
• Responsible for the definition and implementation of the routine process monitoring plan and ensure that process monitoring plan is aligned with the Cleaning Control Strategy and thus the process remains in control.
• Primary responsible for proactively detecting any change in cleaning data variability and identifying/implementing actions as response to it.
• Responsible to drive the cleaning improvement agenda.
• Translate cleaning process requirements and educating Process Teams and operators; design, review, and deliver Process School(s) at the beginning of each campaign, as applicable.
• Responsible for technical documentation of the cleaning program in official sources such as: Process Flow Diagrams (PFDs), Quality Risk Assessments, manufacturing instructions, SOP’s and technical reports.
• Participates in the design and execution of Process, Cleaning, Bioburden Control Strategies and Validation exercises.
• Ensure cleaning process remains in a validated state via routine monitoring, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV) and Annual Product Reviews (APR).
• Responsible to carry out investigations, identify CAPA plans and present them to deviation board.
• Own change controls implementation, which are 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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees