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:
As a Manufacturing Principal Engineer, you will be a technical thought leader, shaping strategy to support the digital transformation of manufacturing. You will be directly accountable for designing the digital backbone of our factories, ensuring our manufacturing and laboratory systems drive tangible business value, from improved batch yields to faster release times. You will shape the architectural vision and long-term roadmap for our Manufacturing Execution Systems (MES) and Laboratory Execution Systems (LES), ensuring they are robust, compliant, and aligned with our "Smart Factory" ambitions. This role is for a seasoned expert who will set technical standards, mentor a team of engineers, and drive the evolution of our manufacturing ecosystem to ensure we remain at the cutting edge of the animal health and pharmaceutical industry.
This includes four strategic priorities:
- Pipeline Acceleration: Optimize the search and approval of high impact medicines with a focus on speed, cost and precision.
- Manufacturing Excellence: Improve the efficiency, quality and consistency of core manufacturing processes, specifically execution and equipment effectiveness.
- Sales Effectiveness: Simplify the process to find, trust and consume relevant customer insights that drive sales growth and improved engagement.
- Productivity: Expand operating margin through efficiency by systematically reducing our operating expenses across the company, improving profitability.
Your Responsibilities:
- Architectural Leadership: Design and own the architectural roadmap for Elanco's enterprise-wide MES/LES platforms. Your vision will ensure our systems are scalable for a global manufacturing network, compliant with international animal health regulations, and capable of supporting future technologies like continuous manufacturing and single-use systems.
- Strategic Process Optimization: Lead initiatives to re-engineer critical manufacturing and lab processes (e.g., biologics, API, sterile fill-finish) through the strategic application of digital technology. You will identify opportunities to improve OEE (Overall Equipment Effectiveness), reduce cycle times, and enhance data integrity.
- Technical Governance and Mentorship: Establish and govern engineering standards and design patterns for MES/LES development, aligned with industry frameworks like GAMP 5. Act as the lead mentor and technical escalation point, fostering a culture of engineering excellence and knowledge sharing across the manufacturing systems team.
- Global Integration Strategy: Define the integration strategy for MES/LES with the broader enterprise systems landscape (SAP ERP, LIMS, PLM, Data Historians). Your work will create a seamless "digital thread" that ensures end-to-end data integrity and full batch genealogy, which is critical for regulatory compliance and product quality.
- Validation and Compliance Strategy: Develop and oversee the global validation strategy for all manufacturing systems. You will ensure our platforms consistently exceed GxP standards and comply with specific regulations such as 21 CFR Part 11 and EU Annex 11, guaranteeing our systems are always "audit-ready".
- Influence Senior Leadership: Serve as a trusted advisor to site and global leadership. You will translate complex technical capabilities into clear business cases, demonstrating the ROI and strategic value of investments in new manufacturing technologies.
- Innovation and Technology Scouting: Proactively identify and evaluate emerging Pharma 4.0 trends (e.g., AI/ML for predictive maintenance, digital twins, advanced process control). You will lead proof-of-concept projects to assess their potential to drive significant business value for Elanco's manufacturing operations.
What You Need to Succeed (Minimum Qualifications):
- Educational Background: A Bachelor's or Master's degree in Engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or a related technical field.
- Required Experience: 8+ years experience. A significant and proven track record leading the design, implementation, and lifecycle management of complex MES/LES solutions within a large-scale pharmaceutical, biologics, or animal health manufacturing environment.
- MES/LES Mastery: Expert-level knowledge of industry-leading MES platforms (e.g., Werum PAS-X, Emerson Syncade, POMSnet) and their application in life science manufacturing, including electronic batch records (EBR) and review-by-exception.
- Pharmaceutical/GxP Leadership: Demonstrated leadership in a highly regulated GxP environment, with deep expertise in pharmaceutical production processes (e.g., sterile/aseptic processing, vaccine manufacturing, quality control testing) and their associated data integrity requirements.
- Architectural and Strategic Thinking: Proven ability to develop multi-year technology roadmaps that align with business strategy and deliver measurable improvements in cost, quality, and speed.
- Technical Mentorship and Leadership: Experience mentoring and developing other engineers, leading complex technical projects, and acting as the definitive subject matter expert for a team.
What Will Give You the Competitive Edge (Preferred Qualifications):
- DevSecOps: Knowledge of relevant DevSecOps concepts and tooling, including Continuous Integration/Continuous Delivery (CI/CD), Git SCM, Containerisation (Docker, Kubernetes), Infrastructure-as-Code (HashiCorp Terraform).
- Cloud Platform Proficiency: Practical experience with Public Cloud, specifically Microsoft Azure and Google Cloud Platform (GCP) and their Automation services (e.g., Azure Logic Apps).
- Regulatory and Validation Expertise: Mastery of computer system validation (CSV) principles based on GAMP 5 and ASTM E2500. Direct experience successfully facing regulatory audits from agencies like the FDA, EMA, and USDA.
- Exceptional Communication and Influence: Ability to articulate a compelling vision for manufacturing technology to diverse audiences, from shop-floor engineers to senior executive leadership.
Additional Information:
- Location: Global Headquarters- Indianapolis, IN (Hybrid environment)
- Travel: Minimal
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 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
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
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
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What We Do
At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives.
Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society.
Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco
