Project Engineer Validation (m/f/d)

Fresenius Medical Care North America; L'Arbresle; Sur place; EUR 45 000 - 80 000; Plein temps

Résumé du poste

An established industry player is seeking a dedicated professional to enhance project management in manufacturing technology and industrialization. This role involves ensuring compliance with regulatory quality constraints, supporting project leaders in documentation, and conducting thorough risk analyses. The ideal candidate will contribute to innovative projects aimed at improving healthcare solutions for patients with chronic conditions. Join a team that values research, innovation, and compassion while making a significant impact on the quality of life for patients every day.

Qualifications

• Experience in managing regulatory quality constraints in projects.
• Strong background in risk analysis and validation strategies.

Responsabilités

• Support project leaders in formalization of project documents.
• Perform process risk analysis and coordinate risk mitigation measures.

Connaissances

Regulatory Quality Constraints

Project Management

Risk Analysis

Validation Strategies

Formation

Bachelor's Degree in Engineering

Master's Degree in Project Management

Description du poste

- Ensure that regulatory quality constraints (ISO, FDA, safety, environment, etc.) are considered in projects managed by Manufacturing Technology & Industrialization.

- Provide support to Manufacturing Technology & Industrialization project leaders on formalization of project documents (URS, FAT, SAT, etc.) and on commissioning phases.

- Perform process risk analysis and coordinate the implementation of risk mitigation measures for projects led by the injection molding and infrastructure technical platform with the support of local teams.

- Draw up validation strategies and documents, and perform validation tests for projects led by the injection molding and infrastructure technical platform according to schedules and safety rules.

About the company

With comprehensive solutions for people living with chronic kidney disease and related conditions, we are working together to improve the quality of life of every patient, every day. We are transforming healthcare through research, innovation, and compassion.