Ambu A/S · 20 hours ago
Process Validation Engineer, Advanced Manufacturing Engineering
Noblesville, IN
Full-time
Onsite
Mid Level
3+ years expAmbu is a company that has been providing innovative medical solutions since 1937. They are seeking a Process Validation Engineer to lead validation aspects of automation and equipment capital projects while ensuring compliance with regulatory standards and facilitating process improvements.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Validation Documents preparation and execution, to ensure all automated systems and/or process improvements are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards, before release to production
Evaluation of validation strategy to ensure quick and compliant transfer of processes and equipment to production
Maintenance of the Agile documents related to processes and equipment, like SOP, flow charts, electrical drawings, 2D/3D drawings, equipment parameter list (CP), equipment logic program (LCP)
Complying with FDA QSR, ISO 13485, and relevant product-specific regulations (e.g., IEC 60601, ISO 14971)
Assist to the design and implementation of automated manufacturing and assembly systems (e.g., robotics, PLCs, vision systems, motion control) to support precision, repeatability, and compliance
Assist to automation and equipment capital projects from concept to installation and validation
The role requires to be “hands on”, on the process and equipment, when needed
Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations
Ability to approve validation protocols, test plans, and reports
Authority to sign off on equipment and process validation documentation
Determine corrective and preventive actions (CAPA) related to validation findings
Qualification
Required
Bachelor's degree in related field and 3 - 5 years of relevant work experience
Five years' experience working in the medical device field
Strong background in medical device process validation, and regulatory compliance
Ability to complete complex reports and correspondence
Must be able to speak, read, write and understand English
Preferred
Bilingual in Spanish is preferred
Company
Ambu A/S
Innovations that make a difference Ever since 1937, Ambu has been rethinking medical solutions to save lives and improve patient care.
5001-10000 employees
H1B Sponsorship
Ambu A/S has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2002-06-28IPO
Leadership Team
Britt Meelby Jensen
Chief Executive Officer
E
Elsebeth Aagaard
Vice President, Regulatory and Clinical Affairs, Biosafety and Sustainability. Global R&D
Recent News
Canada NewsWire
2025-10-23
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