Site Business Process Owner – Digital Manufacturing

Elanco•Indianapolis, IN

7d•Hybrid

About The Position

The Site Business Process Owner – Digital Manufacturing is accountable for successful adoption of Tulip electronic batch records (eBR) and digital shop-floor processes at the site. The role bridges Operations, Quality, IT, and the Global eBR Product Team to translate site manufacturing processes into standardized, compliant, and operator-friendly Tulip applications aligned with global templates and quality expectations. The position owns and standardizes manufacturing processes such as Packaging, Weight & Dispensing, and Logbooks before digitization. It leads the design and deployment of Tulip eBR applications, collaborates with Quality Assurance on GxP compliance, validation, data integrity, and audit readiness, and champions site-level change management, training, and user adoption. The role also resolves eBR execution and workflow issues, monitors KPIs, and identifies process-improvement opportunities. It applies Pharmaceutical Sciences knowledge to industrial manufacturing, including drug manufacturing, quality control, packaging, and regulatory requirements. The position requires 10–20% domestic and international travel. The employee must live within commuting distance of the assigned Elanco office to meet a requirement to work from the office 30 days per quarter.

Requirements

Bachelor’s degree in Engineering, Pharmaceutical Science, a related field, or a foreign equivalent.
At least 3 years of progressively responsible post-baccalaureate experience in the job offered or a related role.
At least 3 years of experience in pharmaceutical manufacturing operations and quality assurance.
At least 3 years of experience managing SOPs, batch records, and deviations in a GMP environment.
At least 3 years of experience with GMP processes combined with process mapping.
At least 3 years of experience in process mapping and optimization using value stream mapping for Manufacturing Execution Systems (MES) Tulip apps.
At least 3 years of experience in data modeling and governance, including structuring tables for materials, batches, and equipment; defining relationships between datasets; and maintaining data integrity and versioning for traceability and compliance.
At least 3 years of experience with shop-floor integration, manufacturing process flows, and defining critical parameters.
At least 3 years of experience with the validation lifecycle (IQ/OQ/PQ), audit trails, electronic records, and alignment with USDA and GMP regulations.
At least 3 years of experience with change management and adoption.
At least 3 years of experience defining and tracking KPIs, including OEE, cycle times, right-first-time performance, scrap/rework rates, and inventory losses.
Must live within commuting distance of the assigned Elanco office to meet the requirement of working from the office 30 days per quarter.
Able to travel 10–20% domestically and internationally.

Responsibilities

Drive successful adoption of Tulip electronic batch records and digital shop-floor processes at the site.
Bridge Operations, Quality, IT, and the Global eBR Product Team to translate manufacturing processes into standardized, compliant, operator-friendly Tulip applications aligned with global templates and quality expectations.
Own and standardize key manufacturing processes, including Packaging, Weight & Dispensing, and Logbooks, and ensure they are defined, documented, and aligned with global standards before digitization.
Lead design and deployment of Tulip eBR applications with global and site teams, translating SOPs and batch records into intuitive digital workflows.
Partner with Quality Assurance to ensure digital processes and Tulip applications meet GxP requirements, support validation, maintain data integrity, and remain audit-ready.
Lead site-level change management and user adoption by promoting digital manufacturing, training operators and supervisors, and fostering continuous improvement.
Resolve eBR execution and workflow challenges.
Monitor KPIs to identify and prioritize process-improvement opportunities.
Apply Pharmaceutical Sciences knowledge to industrial manufacturing processes, including drug manufacturing, quality control, packaging, and regulatory requirements.
Travel domestically and internationally to facilitate and manage Manufacturing Execution System adoption.