What are the responsibilities and job description for the Principal Engineer TSMS Validation position at BioSpace?
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.
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.
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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.
#WeAreLilly
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.
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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.
#WeAreLilly
Salary : $66,000 - $171,600