Eli Lilly and Company · 3 hours ago
Principal Engineer TSMS Validation
Concord, NC
Full-time
Onsite
Senior Level, Lead/Staff
$66K/yr - $172K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. They are seeking a highly experienced Principal Engineer to lead validation activities for their Global TSMS initiatives, ensuring compliance with regulatory requirements and driving continuous improvement in validation practices.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Lead the development, execution, and review of validation strategies, plans, protocols, and reports for complex TSMS projects, ensuring adherence to regulatory requirements
Provide expert technical guidance on validation methodologies, data integrity principles, GxP regulations, and industry best practices related to computerized systems, automation, and manufacturing process controls
Manage validation deliverables across multiple projects, collaborating with cross-functional teams including IT, manufacturing, quality assurance, engineering, and external vendors to ensure timely and effective project completion
Develop and implement risk-based validation approaches, identifying potential risks to system functionality, data integrity, and compliance, and proposing effective mitigation strategies
Contribute to the full lifecycle management of TSMS, from initial design and development through implementation, maintenance, and decommissioning, ensuring continuous validation status
Ensure all validation documentation is accurate, complete, auditable, and compliant with regulatory expectations and company policies. Participate in regulatory inspections and internal audits as a subject matter expert
Proactively identify opportunities for process improvement within TSMS validation, driving efficiency and effectiveness in our validation practices
Mentor engineers and provide training on validation principles and company procedures
Qualification
Required
Bachelor's degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or a related scientific discipline
Minimum of 5 years focused on sterilization or cleaning validation
Strong understanding of manufacturing processes and control systems (e.g., Pharma suite, Maximo)
Experience with various validation tools and methodologies
Proficiency in authoring and reviewing complex validation documentation
Proven leadership skills with the ability to influence and guide cross-functional teams
Excellent written and verbal communication skills, capable of effectively presenting complex technical information to diverse audiences
Strong problem-solving and analytical abilities with a keen attention to detail
Benefits
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