Principal Engineer TSMS Validation
Eli Lilly and Company
4 hours ago
Remote friendly (Concord, NC)
United States
$66,000 - $171,600 USD yearly
IT
Job Summary:
- Lead and execute validation activities for Global TSMS (Technical Systems Management System) initiatives.
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 (IT, manufacturing, quality assurance, engineering) and external vendors.
- Develop and implement risk-based validation approaches to identify and mitigate risks to system functionality, data integrity, and compliance.
- Contribute to TSMS lifecycle management from design/development through implementation, maintenance, and decommissioning, ensuring continuous validation status.
- Ensure validation documentation is accurate, complete, auditable, and compliant; participate in regulatory inspections and internal audits as a subject matter expert.
- Identify opportunities to improve TSMS validation efficiency and effectiveness.
- Mentor engineers and provide validation training.
Qualifications:
- Bachelor’s degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or related scientific discipline.
- Minimum of 5 years focused on sterilization or cleaning validation.
- Legally authorized to work in the United States (no sponsorship anticipated).
Technical Skills:
- Strong understanding of manufacturing processes and control systems (e.g., Pharma suite, Maximo).
- Experience with validation tools and methodologies.
- Proficiency in authoring and reviewing complex validation documentation.
Leadership and Communication:
- Proven ability to influence and lead cross-functional teams.
- Excellent written and verbal communication; presents complex technical information to diverse audiences.
- Strong problem-solving and analytical skills with attention to detail.
Benefits (as stated):
- Company bonus (for full-time equivalents, depending on company and individual performance).
- Eligibility for 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance/death benefits, time off/leave of absence benefits, and well-being benefits.
- Lead and execute validation activities for Global TSMS (Technical Systems Management System) initiatives.
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 (IT, manufacturing, quality assurance, engineering) and external vendors.
- Develop and implement risk-based validation approaches to identify and mitigate risks to system functionality, data integrity, and compliance.
- Contribute to TSMS lifecycle management from design/development through implementation, maintenance, and decommissioning, ensuring continuous validation status.
- Ensure validation documentation is accurate, complete, auditable, and compliant; participate in regulatory inspections and internal audits as a subject matter expert.
- Identify opportunities to improve TSMS validation efficiency and effectiveness.
- Mentor engineers and provide validation training.
Qualifications:
- Bachelor’s degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or related scientific discipline.
- Minimum of 5 years focused on sterilization or cleaning validation.
- Legally authorized to work in the United States (no sponsorship anticipated).
Technical Skills:
- Strong understanding of manufacturing processes and control systems (e.g., Pharma suite, Maximo).
- Experience with validation tools and methodologies.
- Proficiency in authoring and reviewing complex validation documentation.
Leadership and Communication:
- Proven ability to influence and lead cross-functional teams.
- Excellent written and verbal communication; presents complex technical information to diverse audiences.
- Strong problem-solving and analytical skills with attention to detail.
Benefits (as stated):
- Company bonus (for full-time equivalents, depending on company and individual performance).
- Eligibility for 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance/death benefits, time off/leave of absence benefits, and well-being benefits.