Validation Scientist Cleaning & Sterilization Full-time

Validation Scientist In Cleaning & Sterilization

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.

Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly has designed a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help support operations in a state-of-the-art manufacturing site.

Job Summary: As a Validation Scientist in Cleaning & Sterilization at Eli Lilly and Company, you will play a critical role in ensuring the safety, efficacy, and quality of our pharmaceutical products. This is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership with regard to cleaning, sterilization, and temperature mapping validation strategies.

Job Responsibilities:

• Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Lead the design, execution, and documentation of validation studies for manufacturing equipment, ensuring compliance with cGMP, FDA, EMA, and other relevant regulatory guidelines.
• Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs.
• Assist in the development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc).
• Support periodic requalification activities for production equipment and systems.
• Author and support the execution of validation protocols and reports.
• Provide technical guidance to the Process Team for cleaning and sterilization processes.
• Lead or provide technical support for root cause investigations related to cleaning, sterilization, temperature mapping, and other related activities.
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes.
• Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
• Perform risk assessments related to cleaning and sterilization processes and implement appropriate control strategies.
• Develop and maintain strategy documents for Validation.
• Serve as SME interface external to the RTP site in regards to cleaning, sterilization, or temperature mapping.
• Execute, mange, or assist in the execution activities of temperature mapping studies.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Job Qualifications:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Experience supporting cGMP manufacturing (specifically within operations, validation, engineering, technical services/MSAT, quality assurance, etc.)
• Familiarity with various sterilization methodologies (e.g., steam, dry heat, EtO, gamma irradiation)
• Excellent written and verbal communication skills, with the ability to present complex technical information clearly and concisely.
• Strong problem-solving and analytical skills, with a keen attention to detail.
• Ability to work independently and collaboratively in a fast-paced, team-oriented environment.

Preferred:

• Minimum of 3-5 years of experience in the pharmaceutical, biotechnology, or medical device industry, with direct experience in cleaning validation and/or sterilization validation.
• In-depth knowledge of cGMP regulations (21 CFR Parts 210, 211), FDA guidance documents, EU GMP Annex 15, and other relevant international validation standards.
• Proven experience in developing and executing validation protocols and reports.

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.

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.