Sterilization Engineers 2

Our Sterilization Engineers directs implementation and management of sterilization validation, microbiological analysis for product, are responsible for continuous review of FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions and establishes and ensures maintenance of training programs for quality control personnel in regards to sterilization. 

Main Responsibilities:

• Prepare and update quality documents and any applicable documentation required to sustain the product sterilization.
• Execute reviewing / approval of any documentation created / updated by the external Sterilizers required to sustain the product sterilization. 
• Checks, provides support and executes initiation / investigation for NCs, Complaints regarding product sterilization, bioburden, endotoxins, biological indicators, etc.
• Participates in all the readiness activities required to receive Internal / External / Customer Quality System Audits.
• Get involved in various stages of equipment and processes validations: run and / or review protocols and reports for IQ, OQ, PQ and TMV; as well as any other document relating to validation.
• Completes investigation of out of specification for sterilization, product damaged and completion of appropriate documentation for product sterilization.
• Coordinate microbiology testing as offered by the Microbiology Lab, including LAL, Bioburden, sterility testing, EO residuals, etc.
• Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
• Coordinate and collect product samples for product sterilization validation, revalidations, adoptions, etc.  
• Participate, lead and propose new VIP projects providing guidance for other areas as Engineering, Facilities, and Production and into the sterilization area implementing VIP projects.
• Write protocols and reports for Sterilization Validation, completes associated paperwork to ensure proper execution (protocol checklists, laboratory submission forms, etc.), interacts with customers as needed
• Elaboration of Validation Master Plans to define / document all the validation strategy required to implement a new product / process or change a current one. Also, elaborate the Validation Master Plan Closure once all the activities have been executed.
• Collaborate in the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
• Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA regulations (IQ, TMV, OQ and PQ). Prepare respective validation protocols and reports or participate in the approval of them.
• Executes investigations for Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system for the sterilization process.
• Participate in Internal / External / Customer Quality System audits including all the readiness activities and documents explanation to auditors.
• Develop, implement and assure continuance of medical device sterilization validation programs based on regulatory and customer criteria.  
• Develop written procedures to control routine sterilization processing.
• Provide internal consulting to Engineers on new materials and new products to meet material biocompatibility testing requirements.
• Implement various testing programs to assure all materials, the manufacturing environment, environmental control systems and finished products meet all regulatory requirements, including GMP, ISO and Medical Device Directive for sterility and pyrogenicity
• Continuously monitor and evaluate procedures, etc., related to improvements in inefficiencies.  Recommend and, upon approval, develop and implement programs for continual improvement in quality, cost and delivery.
• Develop and perform internal auditing methods as well as audit contract sterilizers.
• Develop action plans to resolve laboratory issues and microbiological concerns that have the potential to impact product sterilization.
• Support and assure proper administration of the document control process, including change control and training related to documentation updates.

Knowledge / Education:

• Minimum education required to perform duties: B.S. in Biotechnology, Biology, Pharmacy, Industrial Engineering or equivalent.
• Bilingual English/Spanish – Intermediate English level.
• Knowledge on FDA Quality System Regulation, Medical Device Directive, ISO 13485, process validation requirements, biocompatibility evaluation standards and other standards that apply to the design, development and sterilization of medical device.
• Knowledge of GMPs, ISO, USP and FDA regulations as they relate to laboratory operations and investigations and sterilization.
• Knowledge of principles, concepts and methodologies of sterilization processes.
• Knowledge and application of statistical techniques (basic descriptive statistics).
• Knowledge in root cause analysis tools.
• Knowledge of Minitab statistical software. 
• Certified Internal Quality Auditor is a plus.

Job Experience: 

• From 3 to 7 years of work experience within the medical device or pharmaceutical in the product sterilization.
• Minimum of 1 year of sterilization validation handling experience.
• Experience supporting operations with bio burden, BI and LAL testing
• Experience in developing or managing sterilization validations and ongoing production in accordance with ISO/AAMI 11135 and 11137

Skills / Competencies: Discipline - Team player - Effective planning and time management - Customer oriented - Diligent - Results oriented - Problem solving - Decision making - Analytical - Innovative

Physical / Licenses Requirements: Usual office environment with frequent sitting, walking, and standing.  - Frequent use of eye, hand, and finger coordination enabling use of office machinery