Senior Process Engineer II - Endotoxin
Senior Process Engineer II - Endotoxin
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1 Vacancy
Job Description
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day our colleagues are challenging whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
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 processengineering 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 seniorlevel 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 117373 USP <85> USP <161> and FDA guidelines.
Ensure proper integration of endotoxin testing within the overall product lifecycle from earlystage development through manufacturing packaging and final product release.
Collaboration & CrossFunctional 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 endotoxinrelated 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
Bachelors or Master of Science degree in Industrial Engineering Biomedical Engineering or similar discipline.
Minimum of 35 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 crossfunctionally.
Detailoriented with a commitment to maintaining highquality 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 117371 USP <85> USP <161> and FDA guidelines.
TOOLS AND EQUIPMENT USED
Knowledge of Visio and other process improvement tools required.
Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.
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Required Experience:
Senior IC
Employment Type
Full-Time
