Senior Sterilization Engineer-Quality/Environmental Controls
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right The primary purpose of this position is to oversee the sterilization of Integer and contract manufactured products, environmental monitoring, product cleanliness, and facility cleanliness across the campus. This individual will be the direct contact for contract sterilization services, lab testing facilities and Integer management regarding cleanliness and sterilization. Responsible for compliance with the requirements of the ISO 13485, European Union Medical Regulation (MDR) - FDA / QSR requirements as well as local, corporate and other geographies. Key Responsibilities Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to:
Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, ISO 13485, European Union Medical Directive Regulation (MDR), company policies and operating procedures, and other regulatory requirements. Provide direction and training to other staff members performing duties in the microbiology area. Complete protocols, final reports, and validations related to sterilization and environmental monitoring. Provide guidance and leadership to product development, production and product transfer teams on sterilization requirements, as well as the environmental impact of new product introductions and production changes. Coordinate manufacturing and product samples required for validation and / or environmental studies. Apply continuous improvement/lean concepts to identify and eliminate non-valued added tasks and/or activities. Demonstrate problem solving methodologies 8D, PDCA, DMAIC to identify root cause and create and implement corrective and preventive actions. Primary customer and regulatory body contact on sterilization and product and environmental cleanliness Site resource for corporate microbiology and sterilization initiatives. Provides technical leadership to technician of junior engineer in the area. Perform other duties as required. Sterilization Develop, validate and maintain sterilization systems for Integer products. Conduct sterile validations, requalification's, and adoptions for new products and product changes in accordance with the applicable standards and Integer procedures for EO (ISO 11135) and alternative sterilization modalities. Write sterilization validation, requalification, and product adoption protocols and reports and periodic reviews. Coordinate and train staff to assure that all functions involved in completing production sterile runs are carried out. Maintain current documents applicable to sterilization processes. Manage sterilization non-conformances and control of non-conforming product. Product and Environmental Controls Establish and maintain controls for chemical and microbiological analysis of in process water (internally and externally sourced). Define environmental monitoring, microbiological assessment and control of products (Bioburden, Endotoxin) across the site Provide leadership in MRB and CAPAs related of environmental controls, Maintains trending data for periodic reporting. Provides guidance for out of specification results Position Requirements Minimal education:
Bachelor's Degree in life science and or engineering. Master's preferred Alternatively two years of experience in a related field may be substituted for every year of education. Minimal
Experience:
5-7 years Sterility Assurance and Microbiology in medical device manufacturing. Specialized Knowledge:
EO sterilization AAMI CISS EO preferred. Knowledge of scientific theories and methods pertaining to bioburden, bacterial endotoxin and water testing. Ability to interpret microbiological data. Working knowledge of ISO 13485, EUU/MDR, QSR/GMP and PMDA Ministry of Health (Japan). ASQ Certification as CQE (Certified Quality Engineer) or Six Sigma Black Belt or Green Belt (Desirable), VHP sterilization (Desirable) U.S. Applicants:
EOE/AA Disability/Veteran.
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical Engineering, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, ISO 13485, European Union Medical Directive Regulation (MDR), company policies and operating procedures, and other regulatory requirements. Provide direction and training to other staff members performing duties in the microbiology area. Complete protocols, final reports, and validations related to sterilization and environmental monitoring. Provide guidance and leadership to product development, production and product transfer teams on sterilization requirements, as well as the environmental impact of new product introductions and production changes. Coordinate manufacturing and product samples required for validation and / or environmental studies. Apply continuous improvement/lean concepts to identify and eliminate non-valued added tasks and/or activities. Demonstrate problem solving methodologies 8D, PDCA, DMAIC to identify root cause and create and implement corrective and preventive actions. Primary customer and regulatory body contact on sterilization and product and environmental cleanliness Site resource for corporate microbiology and sterilization initiatives. Provides technical leadership to technician of junior engineer in the area. Perform other duties as required. Sterilization Develop, validate and maintain sterilization systems for Integer products. Conduct sterile validations, requalification's, and adoptions for new products and product changes in accordance with the applicable standards and Integer procedures for EO (ISO 11135) and alternative sterilization modalities. Write sterilization validation, requalification, and product adoption protocols and reports and periodic reviews. Coordinate and train staff to assure that all functions involved in completing production sterile runs are carried out. Maintain current documents applicable to sterilization processes. Manage sterilization non-conformances and control of non-conforming product. Product and Environmental Controls Establish and maintain controls for chemical and microbiological analysis of in process water (internally and externally sourced). Define environmental monitoring, microbiological assessment and control of products (Bioburden, Endotoxin) across the site Provide leadership in MRB and CAPAs related of environmental controls, Maintains trending data for periodic reporting. Provides guidance for out of specification results Position Requirements Minimal education:
Bachelor's Degree in life science and or engineering. Master's preferred Alternatively two years of experience in a related field may be substituted for every year of education. Minimal
Experience:
5-7 years Sterility Assurance and Microbiology in medical device manufacturing. Specialized Knowledge:
EO sterilization AAMI CISS EO preferred. Knowledge of scientific theories and methods pertaining to bioburden, bacterial endotoxin and water testing. Ability to interpret microbiological data. Working knowledge of ISO 13485, EUU/MDR, QSR/GMP and PMDA Ministry of Health (Japan). ASQ Certification as CQE (Certified Quality Engineer) or Six Sigma Black Belt or Green Belt (Desirable), VHP sterilization (Desirable) U.S. Applicants:
EOE/AA Disability/Veteran.
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical Engineering, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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