Elanco is looking to digitally transform its manufacturing processes to improve efficiency, quality, and consistency, ultimately accelerating the delivery of animal health products and enhancing overall business productivity.
Requirements
- 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.
- 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.
- Proven ability to develop multi-year technology roadmaps that align with business strategy and deliver measurable improvements in cost, quality, and speed.
- Experience mentoring and developing other engineers, leading complex technical projects, and acting as the definitive subject matter expert for a team.
- Knowledge of relevant DevSecOps concepts and tooling, including Continuous Integration/Continuous Delivery (CI/CD), Git SCM, Containerisation (Docker, Kubernetes), Infrastructure-as-Code (HashiCorp Terraform).
- Practical experience with Public Cloud, specifically Microsoft Azure and Google Cloud Platform (GCP) and their Automation services (e.g., Azure Logic Apps).
- Mastery of computer system validation (CSV) principles based on GAMP 5 and ASTM E2500.
Responsibilities
- Architectural Leadership: Design and own the architectural roadmap for Elanco's enterprise-wide MES/LES platforms.
- 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.
- Technical Governance and Mentorship: Establish and govern engineering standards and design patterns for MES/LES development, aligned with industry frameworks like GAMP 5.
- Global Integration Strategy: Define the integration strategy for MES/LES with the broader enterprise systems landscape (SAP ERP, LIMS, PLM, Data Historians).
- Validation and Compliance Strategy: Develop and oversee the global validation strategy for all manufacturing systems.
- Influence Senior Leadership: Serve as a trusted advisor to site and global leadership.
- 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).
Other
- A Bachelor's or Master's degree in Engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or a related technical field.
- 8+ years experience.
- Direct experience successfully facing regulatory audits from agencies like the FDA, EMA, and USDA.
- Ability to articulate a compelling vision for manufacturing technology to diverse audiences, from shop-floor engineers to senior executive leadership.
- Hybrid environment
