Eli Lilly and Company · 13 hours ago
Engineer - TS/MS Cleaning Validation
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The Technical Services and Manufacturing Sciences (TS/MS) Representative for Cleaning Validation is responsible for providing technical leadership in cleaning validation and compliance, supporting day-to-day operations, and collaborating on new product commercialization.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Preferred
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
Benefits
Company bonus
401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
Recent News
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