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IT Manufacturing Principal Engineer
Job in
Indianapolis, Marion County, Indiana, 46262, USA
Listed on 2025-11-29
Listing for:
Elanco Tiergesundheit AG
Full Time
position Listed on 2025-11-29
Job specializations:
-
Manufacturing / Production
Systems Engineer, Manufacturing Engineer
Job Description & How to Apply Below
* ** 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.
** This includes four strategic priorities:
* ** Pipeline Acceleration:
** Optimize the search and approval of high impact medicines with a focus on speed, cost and precision.
* ** 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.
* ** Strategic Process Optimization:**
* ** Technical Governance and Mentorship:**
* ** 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:**
* ** Influence Senior Leadership:**
* ** Innovation and Technology Scouting:
**** 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 (E ) 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.
** 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.
- ** Manufacturing Excellence:
** Improve the efficiency, quality and consistency of core manufacturing processes, specifically execution and equipment effectiveness.
** 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. 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. 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. 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". Serve as a trusted advisor to site and global leadership. You will translate complex technical capabilities into clear…
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