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 technical organization from the ground up.
The Principal Scientist/Engineer – Cleaning Validation/Sterilization Validation – Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies.
Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site.
Key Objectives / Deliverables:
· 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.
· Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs.
· 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, 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.
· Serve as cleaning and sterilization interface external to the Concord site.
· 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.
· BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
· 5+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.)
· In depth knowledge of parenteral drug product manufacturing
· 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
· 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
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