Senior Technical Scientist
Job Summary
Reporting to the Director of Validations, the Senior Technical Scientist is a high-level expert that acts as the technical representative essential to the continuous sterilization process improvement of facilities through statistical analysis of manufacturing processes, failure investigation reporting, experimental studies, results, and recommendations. Responsible for performing studies in compliance with FDA Regulations and ISO / EN sterilization standards and also coordinating consulting projects, technical support for global customers, representing the company in industry interactions and training / mentoring of other employees. They will work to optimize the review of products for sterilization, advancement of sterilization technologies and ongoing technical support for existing products within our facilities. The Senior Technical Scientist will provide management with information and data on all key aspects of corporate validation / technical support projects. Must effectively interface and work closely with Sales, Operations, Corporate EO Technology, Laboratory (if any), EHS, Quality, Engineering and other Sterigenics’ facilities, as well as customers and regulatory personnel.
Major Responsibilities :
The major areas of responsibility include the following :
- Investigates, analyzes, diagnoses, and recommends gas sterilization processes.
o Assist in failure evaluations through investigation and analysis.
o Discover assignable causes.
o Recommend corrective actions.
Performs and coordinates scientific studies to evaluate concepts that ultimately will improve the sterilization process.Assists clients and facilities in the development of scientifically based analysis of processes.May have the function of coordinating the performance of designed experimentation, fractional studies, capability analysis, correlation studies, trend analysis, repeatability, and reproducibility studies to develop and enhance sterilization processes.Provide comprehensive consulting to customers in areas of expertise related to sterile processing and testing of products during the product’s entire life cycleProvide technical support to customers, facilities, operations, sales and laboratoryHandle engineering projects in the pursuit of evaluating new technology, process improvement and associated testing.Assist or lead corporate validation projects and initiatives in the pursuit of efficiency and harmonization across the global validation network.Assist, when necessary, in development of computer programs to enhance the analysis of problems and processes.Implement and make recommendations for necessary datalogger technology associated with customer product validations and plant equipment qualifications. This will include managing the current datalogger software and datalogger calibrator program with in-house calibrations or coordinated vendor service as requiredMentor Technical Advisors and / or facility Validation personnel both formally and informally, to help them provide consistent project management, customer service and reports to customersProvide technical support in customer and regulatory auditsThe position may require leading customer facing validation projects. As such, the position should possess the knowledge, skills, duties, and responsibilities outlined for a Sterigenics Validation Engineer.Travel as necessary (may be up to 25-33% as required) to assist facilities, corporate initiatives and clients.Performs other duties as required to support the overall global validation network and Sterilization Technologies.Knowledge Requirements :
Thorough knowledge and minimum five years’ experience in sterilization processing and with applicable regulatory standardsStrong influencing, leadership and facilitation skillsExcellent communication skills on all levels, including ability to communicate complex technical data to non-technical staffAny additional relevant scientific experienceRequires the ability to communicate technical information effectively in English.Requires the ability to learn and operate software packages as necessary.Problem Solving :
Ability to analyze new processes, perform test studies, and analyze cause and effects analysis, and develop recommendations for process improvement.Ability to design experiments to analyze various factors and their impact on a sterilization process.Ability to analyze processes and process equipment for contribution to sterilization problems.Ability to effectively prioritize activities based on identified needs for improvement of the sterilization technology.Ability to plan, control, organize, and effectively manage all project activities to assure the maintenance of quality.Education & Experience Requirements :
University Degree in a science related field (or international equivalent) such as Chemistry, Chemical Engineering, Microbiology, or other related technical discipline5+ years’ experience with industrial experience in either sterilization or another related field.All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics . LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.
VEVRAA Federal Contractor
