Engineer - TS/MS Cleaning Validation jobs in United States
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Eli Lilly and Company · 10 hours ago

Engineer - TS/MS Cleaning Validation

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines. The Technical Services and Manufacturing Sciences (TS/MS) Representative for Cleaning Validation is responsible for providing technical leadership in cleaning validation and compliance, supporting product commercialization, and improving processes within the Dry Packaging area.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Cleaning ValidationGMP ExperienceTechnical LeadershipRegulatory SubmissionsPharmaceutical ManufacturingRoot Cause InvestigationInterpersonal SkillsOral CommunicationWritten Communication

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
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Company

Eli Lilly and Company

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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 Company
Total Funding
$6.5M
2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO

Leadership Team

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David Ricks
Chair, CEO
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Lucas Montarce
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase