Senior Process Engineer II - Sterilization
Senior Process Engineer II - Sterilization
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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 sterilization processes in the medical device industry. The successful candidate will be responsible for partnering with sterilization 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 sterilization technologies (such as EO steam gamma radiation etc. 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 medical device sterilization processes validation and control 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
Sterilization Process Oversight:
Translate SME knowledge to develop implement and monitor sterilization processes for medical devices to maintain the highest levels of product quality and safety.
Ensure compliance with industry standards such as ISO 13485 ISO 11135 ISO 11137 and FDA requirements.
CrossFunctional Collaboration:
Work closely with R&D manufacturing quality assurance and regulatory teams to ensure sterilization processes are integrated into the overall product development lifecycle. Provide technical guidance on sterilizationrelated concerns throughout the product lifecycle.
Risk Management & Safety:
Ensure that sterilization programs are aligned with broader risk management processes in the company addressing sterilityrelated risks and risks arising from the sterilization process from both a product and patient safety perspective.
Regulatory Compliance & Documentation:
Ensure thorough documentation and records related to sterilization validations and processes including process flow diagrams standard operating procedures and sterilization 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 sterilization processes including cycle design validations and maintenance of validated state.
Strong understanding of product risk management processes.
Experience creating and changing procedures for establishing validating and controlling critical processes within the medical device industry.
Awareness of applicable sterilization standards including but not limited to ISO 11135 ISO 11137 ISO 11737 ISO 17665 ISO 11138 ISO 22441 and other applicable standards for medical device sterilization.
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
