Principal Engineer TSMS Validation

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Principal Engineer TSMS Validation - Eli Lilly and Company

Job Summary

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

Responsibilities

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.

Qualifications

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.
 

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Actual compensation will depend on a candidate's education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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