Site Business Process Owner – Digital Manufacturing

Elanco • Indianapolis, IN

6d

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, ensuring that manufacturing processes are translated into standardized, compliant, operator-friendly Tulip applications aligned with global templates and quality expectations.

The role owns and standardizes manufacturing processes such as Packaging, Weight & Dispensing, and Logbooks before digitization. It partners with global and site teams to design and deploy Tulip eBR applications, translating SOPs and batch records into digital workflows. It works with Quality Assurance to meet GxP requirements, support validation, and maintain data integrity and audit readiness. The position also leads site-level change management, training, issue resolution, and continuous improvement, using KPIs to identify and prioritize 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 to facilitate and manage Manufacturing Execution System adoption. The employee must live within commuting distance of the assigned Elanco office and 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 managing data integrity and versioning for traceability and compliance.
• At least 3 years of experience with shop-floor integration, manufacturing process flow, 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 in change management and adoption.
• At least 3 years of experience defining and tracking KPIs, including OEE, cycle times, right-the-first-time, scrap/rework rates, and inventory losses.
• Must live within commuting distance of the assigned Elanco office location.
• Must meet the requirement to work from the office 30 days per quarter.

Responsibilities

• Drive successful site adoption of Tulip electronic batch records and digital shop-floor processes.
• Bridge Operations, Quality, IT, and the Global eBR Product Team to ensure site processes are translated into standardized, compliant, operator-friendly Tulip applications.
• Own and standardize manufacturing processes, including Packaging, Weight & Dispensing, and Logbooks, and ensure they are documented and aligned with global standards before digitization.
• Lead the design and deployment of Tulip eBR applications with global and site teams, translating SOPs and batch records into operator-friendly digital workflows.
• Collaborate with Quality Assurance to ensure digital processes and applications meet GxP requirements, support validation, and maintain data integrity and audit readiness.
• Lead site-level change management and user adoption, including championing digital manufacturing and training operators and supervisors.
• Lead resolution of eBR execution and workflow issues.
• 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.

What This Job Offers

• Job Type: Full-time