Validation Engineer – TSMS

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 is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina.  This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. 

The Validation Technician – TSMS (Technical Services / Manufacturing Science) role is a technical position that supports the validation of production equipment and processes such as temperature mapping and cleaning/sterilization validation.

Primary objectives include the start-up and compliant manufacturing of Concord products, particularly as it relates to implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities.  May also support additional validation activities in device assembly, packaging, and syringe filling operations.

Key Objectives / Deliverables:

• Execute validation studies/protocols (placing BI’s, dataloggers, soiling equipment, performing swabs, etc), providing technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs.
• Prepare and Review, as required, relevant technical documents, such as: Change Controls, Reports, Deviations, Validations, Procedures , Protocols, PFDs, pFMEAs, etc.
• Identify opportunities and participate in projects to improve process control and/or productivity.
• Support periodic requalification activities for production equipment and systems ((e.g., component/parts washer, autoclaves, filling isolators, etc).
• Author and support the execution of validation protocols and reports.
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Participate 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 TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Minimum Requirements:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

Additional Preferences:

• Experience executing equipment qualification, cleaning validation, and sterilization validation
• Demonstrated successful leadership of cross-functional teams
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems
• Experience supporting cGMP manufacturing (within operations, validation, engineering, technical services/MSAT, quality assurance, etc.)

Other Information:

• Role is Monday through Friday based.  Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).  Occasional extended hour and / or off-hour work may be required.
• Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly sites as required

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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