Job Description

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 scientific and process data to support process robustness, compliance, and continuous improvement.

What will give you a competitive edge (preferred qualifications):

• Experience with Process Validation, Cleaning Validation, Aseptic Process Simulation, Filter Validation, Performance Qualification, or warehouse mapping.
• Understanding of root cause investigations and supporting Corrective and Preventive Actions (CAPA).
• Basic knowledge of Validation Master Plans, Product Quality Reviews, Process Capability Assessments.
• Awareness of or exposure to technical transfers, new product scale-ups, and process optimization.
• Familiarity with collaborating with internal and external stakeholders in a pharmaceutical manufacturing environment.

Additional Information:

Travel: Not required
Location: Ansan (Banwol), Korea

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco 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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.