Engineer - TS/MS Cleaning Validation
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. 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. Position Brand Description: The Technical Services and Manufacturing Sciences (TS/MS) Representative for Cleaning Validation is a technical position that supports, develops and implements a technical agenda for their area of responsibility. The TS/MS Representative is responsible for providing technical leadership for activities within Indianapolis Device Assembly & Packaging (IDAP), including new product commercialization and commercial product support. This position focuses specifically on Dry Packaging which includes bottle and blister card filling and packaging for tablets and capsules. Primary objectives include cleaning validation, cleaning compliance, continuous improvement of processes, and supporting day-to-day operations of Process Teams.
Requirements
- Bachelor’s degree or equivalent in a STEM discipline
- Minimum 2 years of experience, with at least 1 year with cleaning/cleaning validation in a GMP environment
Nice To Haves
- Technical / Scientific knowledge of cleaning regulatory requirements and practices
- Clear understanding of cGMPs
- Experience in pharmaceutical manufacturing
- Good teamwork and interpersonal skills
- Root Cause Investigation experience
- Experience in technical leadership
- Oral and written communication skills that demonstrate effective communication with all levels of an organization
Responsibilities
- Execute the technical agenda for the Dry Packaging cleaning and cleaning validation
- Prepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.
- Lead technical projects to improve cleaning processes and compliance
- Benchmark with sites in the network to drive technical consistency and knowledge sharing
- Serve as interface with upstream suppliers and Dry product network
- Own cleaning batch records and revisions, ensuring they are current and accurate
- Support equipment commissioning and qualification activities, as required
- Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP
- Understand the scientific principles required for Dry Packaging operations
- Support regulatory submissions as needed
- Understand and implement global requirements and standards into the Dry Process Team
- Provide technical leadership for the Process Team for cleaning activities
- Provide off hours support as needed
Benefits
- Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
- 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).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
