Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS)

Elanco in; Elwood (KS); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus offering Up to 6%

401K matching

Résumé du poste

Elanco in Elwood, Kansas seeks an Investigation Specialist - Technical Services / Manufacturing Sciences to lead root cause investigations and CAPA in monoclonal antibody production. You will collaborate across functions to ensure thorough documentation and compliant resolution.

Responsibilities include authoring investigation reports, deviations, change controls, SOPs, and supporting continuous improvement in a GMP environment. Relocation considered; travel occasional.

Qualifications

• Bachelor’s degree in a STEM-related field.
• Minimum of 3 years of experience in a GMP-regulated environment, with at least 2 years leading or supporting root cause investigations.
• Strong root cause investigation and problem-solving capabilities; ability to collaborate cross-functionally while producing clear, high-quality technical documentation.
• Understanding of quality systems, including deviations, CAPA, and change control processes.

Responsabilités

• Lead and facilitate root cause investigations for quality and safety events, ensuring timely, thorough, and compliant resolution.
• Collaborate with cross-functional teams to support and mentor staff on investigation methodologies and technical writing best practices.
• Author and review technical documentation including investigation reports, impact assessments, deviations, change controls, CAPAs, and SOPs.
• Drive continuous improvement initiatives through data analysis, Kaizen events, and KPI-driven discussions to enhance manufacturing performance.
• Perform risk and impact assessments to support decision-making and ensure regulatory compliance.
• Ensure adherence to GMP standards and internal quality systems while promoting a strong culture of safety, quality, and accountability.

Connaissances

Root cause investigation

Cross-functional collaboration

Technical writing

GMP quality systems

Formation

Bachelor’s degree in STEM

Description du poste

About Elanco

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! Please note, this is a fixed term duration position, you will still be eligible for benefits.

Your Role

The Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS) is responsible for leading and supporting root cause analysis and quality event management for monoclonal antibody (mAb) production at the Elwood, Kansas site. This role partners closely with cross-functional teams to drive thorough investigations, ensure high-quality documentation, and implement effective corrective and preventive actions (CAPA). The position plays a key role in strengthening compliance, improving processes, and fostering a culture of quality and continuous improvement.

Your Responsibilities

• Lead and facilitate root cause investigations for quality and safety events, ensuring timely, thorough, and compliant resolution.
• Collaborate with cross-functional teams to support and mentor staff on investigation methodologies and technical writing best practices.
• Author and review technical documentation including investigation reports, impact assessments, deviations, change controls, CAPAs, and standard operating procedures (SOPs).
• Drive continuous improvement initiatives through data analysis, Kaizen events, and KPI-driven discussions to enhance manufacturing performance.
• Perform risk and impact assessments to support decision-making and ensure regulatory compliance.
• Ensure adherence to GMP standards and internal quality systems while promoting a strong culture of safety, quality, and accountability.

What You Need to Succeed (minimum qualifications)

• Education: Bachelor’s degree in a STEM-related field.
• Experience: Minimum of 3 years of experience in a GMP-regulated environment, with at least 2 years leading or supporting root cause investigations.
• Top 2 Skills: Strong root cause investigation and problem-solving capabilities; and the ability to collaborate cross-functionally while producing clear, high-quality technical documentation.
• Strong understanding of quality systems, including deviations, CAPA, and change control processes.

What will give you a competitive edge (preferred qualifications)

• Experience in commercial monoclonal antibody or recombinant protein manufacturing.
• Demonstrated strength in technical writing and documentation.
• Six Sigma Green Belt (or higher) or equivalent continuous improvement training.
• Formal training in root cause analysis methodologies (e.g., DMAIC, 5 Whys, Fishbone).
• Proven ability to collaborate across cross-functional teams, with strong coaching and communication skills.

Additional Information

Location: Elwood, Kansas

Travel: Occasional (<10%) This role operates during standard business hours with occasional off-hours support in a 24/7/365 manufacturing environment.

Elanco Benefits and Perks

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering Up to 6%
• 401K matching
• #LI-HL #LI-Onsite

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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.