Process Engineer -IVD

Sigma-Aldrich Manufacturing LLC•St. Louis, MO

About The Position

The Process Engineer is responsible for the development, optimization, and implementation of manufacturing processes within an organization. The successful candidate will be part of a team of process engineers, ensuring collaboration across various departments, such as R&D, production, and quality assurance. Key responsibilities include managing projects, assisting team members when needed, troubleshooting process issues, ensuring compliance with industry standards, and utilizing data analytics for performance monitoring and improvement. This role supports the manufacture of regulated in vitro diagnostic (IVD) products within a Quality Management System (QMS), ensuring process compliance, validation, and robust product quality.

Requirements

Bachelor's Degree in Engineering (Chemical, Mechanical, or Industrial, etc.).
3+ years of experience in process engineering, with a focus on manufacturing processes.

Nice To Haves

Lean Six Sigma training (Blue, Green or Black belt).
Experience supporting tabletting processes (e.g., blending/granulation, compression, in-process controls, troubleshooting).
Experience supporting process/equipment validation in a regulated environment (e.g., IQ/OQ/PQ, PPQ), including execution support, deviation handling, and documentation within a QMS (change control, CAPA).
Leadership experience
Proficiency in process simulation software, data analysis tools, and project management software.
Strong analytical skills and the ability to troubleshoot complex engineering problems.
Excellent verbal and written communication skills to effectively collaborate with team members and stakeholders.

Responsibilities

Lead the design, implementation, and refinement of manufacturing processes to maximize operational efficiency, minimize costs, and ensure superior product quality.
Ensure all processes adhere to IVD regulations and safety standards, managing critical documentation for IQ/OQ/PQ validation, risk management, and lifecycle controls.
Partner closely with R&D, Production, and Quality Assurance to facilitate the seamless transition of new products and processes into a manufacturing environment.
Oversee engineering projects from initial conception through final execution, ensuring strict adherence to established timelines, budgets, and technical specifications.
Identify and resolve complex process deviations and equipment issues, implementing effective Corrective and Preventive Actions (CAPA) to maintain continuity.
Utilize advanced data analytics and process simulation tools to monitor performance trends and drive continuous improvement initiatives.
Drive a culture of technical excellence by training and mentoring team members in industry best practices, safety guidelines, and professional development standards.