Manager of Manufacturing Applications - Onsite

Danaher•Fargo, ND

3d•Onsite

About The Position

The Manager of Manufacturing Applications is responsible for ensuring compliant, reliable, and validated enterprise manufacturing platforms that support GxP‑regulated operations across the organization. This position reports to the Director of Software Engineering and is part of the IT Manufacturing Applications team located in Coralville, IA or Fargo, ND and will be an on-site role. In this role, you will have the opportunity to Own the end‑to‑end management of GxP‑regulated manufacturing systems, including lifecycle planning, enhancements, upgrades, rationalization, and decommissioning. Ensure manufacturing systems operate in compliance with GxP regulations, internal quality standards, and inspection readiness expectations. Coordinate with the Validation team and govern change management for GxP systems, including validation planning, risk assessments, testing, documentation, change impact analysis, and ensuring changes are properly assessed, approved, tested, and deployed in alignment with validation and quality requirements. Partner closely with Quality, Manufacturing, and IT stakeholders to translate operational needs into compliant system capabilities and improvements. Oversee operational stability and performance of GxP systems, including incident management, root cause analysis, corrective and preventive actions (CAPAs), and continuous improvement. Manage vendors and service partners supporting GxP systems, ensuring compliance, performance, documentation, and service expectations are met. Maintain inspection-ready documentation, support internal and external audits and regulatory inspections, and coordinate training and user enablement to ensure proper system use and sustained compliance.

Requirements

Bachelor’s degree in Information Technology, Engineering, Life Sciences, or a related discipline.
At least 8–10 years of experience supporting or managing manufacturing IT systems in regulated environments, including experience with technically complex systems involving integrations, automation, or custom implementations.
Demonstrated experience managing GxP‑regulated systems, including validation support, compliance oversight, and change control in collaboration with Quality and Validation teams, and partnering with Manufacturing and Quality organizations to support compliant operations.
Strong understanding of manufacturing systems (e.g., MES, LIMS, QMS, instruments related, or related manufacturing platforms).
Experience operating within IT service management and quality governance processes, with hands‑on software development experience supporting system integrations, automation, or platform enhancements, using technologies such as C#, JavaScript/TypeScript, modern web frameworks (e.g. React), and API‑based integrations.

Nice To Haves

Experience supporting global or multi site manufacturing environments.
Exposure to manufacturing digital transformation initiatives.
Experience with ERP–manufacturing system integrations in regulated contexts.

Responsibilities

Own the end‑to‑end management of GxP‑regulated manufacturing systems, including lifecycle planning, enhancements, upgrades, rationalization, and decommissioning.
Ensure manufacturing systems operate in compliance with GxP regulations, internal quality standards, and inspection readiness expectations.
Coordinate with the Validation team and govern change management for GxP systems, including validation planning, risk assessments, testing, documentation, change impact analysis, and ensuring changes are properly assessed, approved, tested, and deployed in alignment with validation and quality requirements.
Partner closely with Quality, Manufacturing, and IT stakeholders to translate operational needs into compliant system capabilities and improvements.
Oversee operational stability and performance of GxP systems, including incident management, root cause analysis, corrective and preventive actions (CAPAs), and continuous improvement.
Manage vendors and service partners supporting GxP systems, ensuring compliance, performance, documentation, and service expectations are met.
Maintain inspection-ready documentation, support internal and external audits and regulatory inspections, and coordinate training and user enablement to ensure proper system use and sustained compliance.