Eli Lilly and Company · 8 hours ago
TS/MS Engineer – Cleaning Validation/Sterilization Validation
Concord, NC
Full-time
Onsite
Mid Level
$66K/yr - $172K/yr
3+ years expEli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. The TS/MS Engineer role focuses on developing and supporting validation strategies for production equipment and systems, particularly in cleaning and sterilization processes within a new manufacturing facility.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs
Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc)
Support periodic requalification activities for production equipment and systems
Author and support the execution of validation protocols and reports
Provide technical guidance to the Process Team for cleaning and sterilization processes
Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities
Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements
Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes
Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed
Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc
Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda
Serve as cleaning and sterilization interface external to the Concord site
Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities
Qualification
Required
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.)
Preferred
In depth knowledge of parenteral drug product manufacturing
Experience executing equipment qualification, cleaning validation, and sterilization validation
Demonstrated successful leadership of cross-functional teams
Experience with data trending and analysis
Ability to analyze complex data and solve problems
Benefits
Company bonus (depending, in part, on company and individual performance)
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
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.
10001+ employees
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
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2025-12-30
2025-12-30
Company data provided by crunchbase