Technical Service Manufacturing Science (TSMS) Specialist

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: TSMS Specialist

As a TSMS Specialist, you will support the comprehensive management of validation, qualification, process monitoring, and technical documentation at sterile injectable manufacturing site in Ansan.

In this role, you will provide technical support for manufacturing processes and equipment, promote process improvement, and help ensure robust, compliant, and efficient operations.

Your Responsibilities:


* Lead site validation and qualification activities, including Process Validation, Cleaning Validation, Aseptic Process Simulation (Media Fill), Filter Validation, Performance Qualification (PQ), and warehouse mapping studies


* Investigate complex manufacturing issues related to yield, quality, and throughput; lead root cause investigations and support the development of Root Cause and Preventive Solutions (RCPS) and Corrective and Preventive Actions (CAPA).


* Prepare, manage, and update the Validation Master Plan (VMP), Product Quality Reviews (PQR), Process Capability Assessments, Process Flow Documents (PFD), Internal Alert Limit (IAL) assessments, and Distribution Temperature Profiles (DTP).


* Review Standard Operating Procedures (SOPs), prepare Chemistry, Manufacturing and Controls (CMC) documentation, provide technical support for overseas registrations, and support technical transfers, new product scale-ups, and process optimization activities.


* Monitor critical process data, including Ongoing Process Monitoring (OPM), to assess process robustness and identify opportunities for improvement.

What You Need to Succeed (minimum qualifications):


* Bachelor’s degree in Pharmaceutical Engineering, Chemistry, Biology, or a related scientific field.


* A minimum of 5 years of professional experience in a sterile injectable Good Manufacturing Practice (GMP) environment, with a strong understanding of production quality systems.


* Proven experience managing validation and qualification programs, including the preparation and review of technical documentation.


* Fluency in both written and spoken Korean and English.


* Experience analyzing s...