Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This role will be based out of the Ambu America's Center of Excellence located at the Noblesville, Indiana manufacturing facility. The role has overall responsibility for the Advanced Manufacturing Engineering functions of both the Noblesville, IN and the Juarez, MX manufacturing sites. The expected travel for this role is up to 50%.
Objective:
The Process Validation Engineer leads the validation aspects of Automation and Equipment Capital projects, process improvements, supports the development of automated solutions, is responsible of the validation of new equipment installation, ensuring seamless process transfer and readiness to production.
Responsibilities and Essential Functions:
Compliance and Validation:
- 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).
- Operational & Regulatory Excellence
Automation & Smart Manufacturing:
- 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.
Operational Excellence:
- Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations.
Authorities:
- 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.
Work Environment:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.
Qualifications:
- 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.
- Bilingual in Spanish is preferred.
Ambu Provided Training within the first six months:
- Agile, Change Control System
- Movex, ERP System
- Medius, Procurement System
- Validation Training
About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.