Senior Process Engineer II - Endotoxin

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Summary

We are seeking a highly skilled and motivated Senior Process Engineer II with a focus on bacterial endotoxin testing programs in the medical device industry. The successful candidate will be responsible for partnering with bacterial endotoxin Subject Matter Experts to interpret and translate requirements into compliant and harmonized systems and procedures. This role requires a strong process-engineering mindset, a willingness to learn about bacterial endotoxin testing programs, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The candidate must be a senior-level professional/team player with advanced process engineering knowledge and a propensity to lead successful teams. An understanding of bacterial endotoxin testing programs is preferred. The qualified candidate must understand the concepts of risk management as it relates to bacterial endotoxin monitoring in a medical device manufacturing environment.

Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

Team Leadership & Development:

• Lead, listen to, and manage a team of subject matter experts responsible for implementing and optimizing bacterial endotoxin control programs in medical device manufacturing.
• Foster a collaborative environment by promoting knowledge sharing, training, and professional growth within the team.
• Manage team performance and set clear objectives to ensure that all goals are met efficiently and in compliance with industry standards.
• Support the Environmental Controls Senior Manager with providing direction to the team, coordinating workflow, and providing guidance in the resolution of problems or areas of concern
  
  

Bacterial Endotoxin Process Oversight:

Translate SME knowledge to manage the development, implementation, and validation of bacterial endotoxin control programs, ensuring compliance with relevant regulatory requirements such as ANSI/AAMI ST72, ISO 11737-3, USP , USP , and FDA guidelines.

Ensure proper integration of endotoxin testing within the overall product lifecycle, from early-stage development through manufacturing, packaging, and final product release.

Collaboration & Cross-Functional Support:

• Work closely with quality assurance and production teams to integrate endotoxin control practices within broader quality systems and manufacturing processes.
• Collaborate with the sterilization and contamination control teams to ensure endotoxin levels are considered and controlled throughout the product lifecycle.
  
  

Risk Management & Safety:

• Lead risk assessments related to endotoxin control, identifying potential sources of contamination and implementing strategies to mitigate risks.
• Ensure that endotoxin testing and control programs are aligned with broader risk management processes in the company, addressing endotoxin-related risks from both a product and patient safety perspective.
  
  

Regulatory Compliance & Documentation:

• Ensure thorough documentation and records related to contamination control, including process flow diagrams, standard operating procedures, and endotoxin program management tools.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
  
  

Desired Minimum Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position

• Bachelor degree with 8 years of experience or equivalent education and years of experience
• Master degree with 5 years of experience or equivalent education and years of experience
• Doctoral degree with 3 years of experience or equivalent education and years of experience
• Bachelor’s or Master of Science degree in Industrial Engineering, Biomedical Engineering or similar discipline.
• Minimum of 3-5 years of experience in process engineering
• Demonstrates excellent leadership and organizational skills.
• Excellent process mapping skills with an understanding of good documentation practice.
• Strong written and verbal communication skills.
• Proven ability to lead a team, manage multiple projects, and work cross-functionally.
• Detail-oriented with a commitment to maintaining high-quality standards and regulatory compliance.
• Experience with quality management systems (QMS) and CAPA processes.
  
  

Preferred Skills:

Familiarity with bacterial endotoxin control methods, including LAL (Limulus Amebocyte Lysate) testing, recombinant Factor C assay, and endotoxin limit specifications.

Experience creating and changing procedures used in operations for testing of the environment and products.

Awareness of applicable endotoxin standards including, but not limited to, ANSI/AAMI ST72, ISO 11737-1, USP , USP , and FDA guidelines.

TOOLS AND EQUIPMENT USED

• Knowledge of Visio and other process improvement tools required.
  
  

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