Responsibilities:
1. 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.
2. Strategic Process Optimisation: Lead initiatives to re-engineer critical manufacturing and lab processes (, 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.
3. 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.
4. 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.
5. 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".
6. 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.
7. Innovation and Technology Scouting: Proactively identify and evaluate emerging Pharma trends (, 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):
8. Education: A Bachelor's or Master's degree in Engineering (, Industrial, Chemical, Manufacturing, Computer Science) or a related technical field.
9. Extensive Industry 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.
10. MES/LES Mastery: Expert-level knowledge of industry-leading MES platforms (, Werum PAS-X, Emerson Syncade, POMSnet) and their application in life science manufacturing, including electronic batch records (EBR) and review-by-exception.
11. Pharmaceutical/GxP Leadership:Demonstrated leadership in a highly regulated GxP environment, with deep expertise in pharmaceutical production processes (, sterile/aseptic processing, vaccine manufacturing, quality control testing) and their associated data integrity requirements.
12. 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.
13. 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.
14. 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).
15. Cloud Platform Proficiency: Practical experience with Public Cloud, specifically Microsoft Azure and Google Cloud Platform (GCP) and their Automation services (, Azure Logic Apps).
16. 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.
17. 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:
18. Travel:0-10%
19. Location: Hook, UK - Hybrid Work Environment