Scientist – TS/MS Validation

Industry:

Company: Eli Lilly and Company

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 – $167,200

Position Brand Description:

The Validation Scientist is responsible for the technical ownership and successful execution of the Validation Program at the Indianapolis Parenteral Manufacturing Site. TS/MS Validation personnel provide stewardship of the site’s Validation Program, including assessment of and improvement in existing controls.

Responsibilities:

• Maintenance and continuous improvement of the Validation programs
• Write validation protocols and reports in support of the site’s validation programs
• Investigate and troubleshoot problems which occur during cleaning, sterilization, and temperature mapping
• Plan and execute validation activities, including cross-functional coordination and internal coordination with Validation Specialists
• Prepare and provide technical review of completed/executed validation packages by compiling and analyzing validation data for submittal for review and approval
• Lead resolution of validation deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
• Maintain an up-to-date knowledge of validation requirements, practices, and procedures
• Write validation plans and risk assessments related to specific projects, facilities, products
• Write and review policies and procedures (SOPs)
• Perform risk assessments for validation programs
• Perform and/or coordinate validation studies, testing, verification, and sampling
• Provide technical input for control strategies for the introduction of new products (e.g. CTs), as it relates to Cleaning, Filter, Sterilization, and Temperature Mapping Validation
• Write and execute IQ/OQ/PQ/ and cycle development protocols including development of final reports
• Represent/defend validation strategies during internal assessments / audits and external regulatory inspections

Basic Requirements:

• Bachelor’s degree required, preferably in a scientific discipline (Chemistry, Biology, Pharmacy, Engineering or a related field).
• Minimum of 3 years of validation experience required.

Additional Preferences:

• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Attention to detail, excellent review skills and analytical skills
• Understanding of cGMPs and applicable internal standards
• Ability to drive change and motivate others toward a common vision
• Ability to effectively influence others and lead others that are not direct reports
• Demonstrated facilitation, problem solving, and analytical skills
• Must have strong ability to organize and manage multiple tasks in a fast-paced environment
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• Experience in Operations, TS/MS, QA, QC, Regulatory, or Supply Chain within pharmaceutical manufacturing
• Demonstrated understanding reviewing/writing technical documents, risk assessments/impact assessments, validation documents, IOQ protocols and final reports
• Hands-on experience supporting/executing qualifications related to various processes and activities

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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