Principal Engineer TSMS Validation

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.

We are seeking a highly experienced Principal Engineer to lead and execute validation activities for our Global TSMS (Technical Systems Management System) initiatives.

• Validation Leadership:
  Lead the development, execution, and review of validation strategies, plans, protocols, and reports for complex TSMS projects, ensuring adherence to regulatory requirements.
• Technical Expertise:
  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.
• Project Management:
  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.
• Risk Management:
  
  Develop and implement risk‑based validation approaches, identifying potential risks to system functionality, data integrity, and compliance, and proposing effective mitigation strategies.
• System Lifecycle Management:
  Contribute to the full lifecycle management of TSMS, from initial design and development through implementation, maintenance, and decommissioning, ensuring continuous validation status.
• Documentation and Compliance:
  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.
• Continuous Improvement:
  Proactively identify opportunities for process improvement within TSMS validation, driving efficiency and effectiveness in our validation practices.
• Mentorship and Training:
  Mentor engineers and provide training on validation principles and company procedures.

• Education:
  
  Bachelor’s degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or a related scientific discipline.
• Experience:
  
  Minimum of 5 years focused on sterilization or cleaning validation.
• Technical
  
  Skills:
  • 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.
• Leadership and Communication:
  • 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form  for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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