GxP Manufacturing Systems Lead

Radiometer

Coralville (IA)

On-site

USD 95,000 - 140,000

Full time

8 days ago

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Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

Integrated DNA Technologies (IDT) is seeking a Manager of Manufacturing Applications to lead end-to-end GxP-regulated manufacturing systems. The role is onsite in Coralville, Iowa, or Fargo, North Dakota, reporting to the Director of Software Engineering.

You will shape lifecycle planning, validation, and change control with cross-functional partners to ensure compliant operations. The ideal candidate has a BS in IT/engineering/life sciences, 4+ years in regulated manufacturing IT, and 1+ year

Qualifications

Bachelor's degree in IT, engineering, life sciences, or related field.
4+ years in regulated manufacturing IT systems, with 1+ year in a lead role.
Strong knowledge of MES/LIMS/QMS and IT service management with hands-on dev experience (C#, JS/TS, React).

Responsibilities

Own end-to-end management of GxP-regulated manufacturing systems from lifecycle planning to decommissioning.
Ensure systems comply with GxP regulations, quality standards, and inspection readiness.
Coordinate validation activities, risk assessments, testing, and change control with Validation teams.
Collaborate with Quality, Manufacturing and IT to translate operations needs into compliant system capabilities.
Maintain inspection-ready docs and support audits and regulatory inspections.