Automation & Validation Project Engineer

Ambu A/S; Noblesville (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Ambu A/S in Noblesville, Indiana seeks a Project Validation Engineer in Advanced Manufacturing to lead automation projects and validate new equipment for production. The role covers Noblesville and Juarez sites, with up to 50% travel. Strong focus on FDA/ISO compliance and process validation.

The ideal candidate has a bachelor’s degree and 6–8 years in automation, plus 5 years in medical devices, with hands‑on problem solving and cross‑site coordination.

Qualifications

• Bachelor’s degree and 6–8 years of relevant experience in manufacturing or automation.
• Five years’ experience managing automation projects.
• Five years’ experience in the medical device field.
• Strong background in process validation and regulatory compliance.
• Excellent reporting and written communication skills.
• English fluency; bilingual in Spanish preferred.

Responsibilities

• Lead automation and equipment capital projects from concept to installation and validation.
• Collaborate with suppliers and internal teams to deploy automated manufacturing solutions.
• Ensure readiness and validation of new equipment (IQ/OQ/PQ) for production.
• Track savings, KPIs, and project outcomes; maintain engineering documentation.

Skills

Process validation

Regulatory compliance

Documentation

Leadership

Communication

Education

Bachelor's degree in related field

Tools

PLCs

Vision systems

MES

SCADA

IIoT

Job description

Ambu A/S in Noblesville, Indiana seeks a Project Validation Engineer in Advanced Manufacturing to lead automation projects and validate new equipment for production. The role covers Noblesville and Juarez sites, with up to 50% travel. Strong focus on FDA/ISO compliance and process validation.

The ideal candidate has a bachelor’s degree and 6–8 years in automation, plus 5 years in medical devices, with hands‑on problem solving and cross‑site coordination.