Senior Process Engineer II - CEA Controls
Senior Process Engineer II - CEA Controls
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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 a focus on manufacturing contamination control in the medical device industry. The successful candidate will be responsible for partnering with microbiology 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 contamination control and controlled manufacturing environments an understanding of medical device quality systems and a commitment to ensuring product safety and compliance. This role is critical to ensuring the integrity safety and compliance of our manufacturing processes particularly in cleanroom environments where stringent contamination control practices are essential to product quality. The candidate must be a seniorlevel professional/team player with advanced process engineering knowledge and a propensity to lead successful teams. An understanding of clean room practice/cGMP and laboratory/GLP environments is preferred. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment.
ESSENTIAL DUTIES AND 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 contamination 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
Contamination Control Process Oversight:
Translate SME knowledge to develop implement and monitor contamination control processes and strategies to maintain the highest levels of product quality and safety in manufacturing environments including cleanrooms.
Ensure compliance with industry standards such as ISO 14644 EN17141 ISO 13485 FDA regulations and other relevant guidelines governing contamination control in medical device manufacturing.
CrossFunctional Collaboration:
Collaborate closely with crossfunctional teams (e.g. quality assurance regulatory affairs R&D production) to ensure contamination control practices are integrated into product design and manufacturing processes.
Risk Management & Safety:
Ensure that contamination control programs are aligned with broader risk management processes in the company addressing microbial contaminationrelated 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 contamination control program management tools.
Ensure that all projects are in compliance with cGMP cGLP QSR (including Design Controls) ISO or other applicable requirements.
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 contamination control processes including microbial contamination cleanroom protocols controlled environment monitoring water system monitoring compressed air monitoring and bioburden testing.
Experience creating and changing procedures used in operations for testing of the environment and products.
Awareness of ISO 14644 ISO 13485 FDA regulations and other relevant guidelines/standards governing contamination control in medical device manufacturing.
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
