Validation Engineer

BGS, a leading services provider of beta rays for radiation sterilization, is currently staffing US-based operations at our new production facility in Imperial, PA.We are seeking an enthusiastic and safety-oriented Validation Engineer, versed in both electrical and mechanical operations. In this position, you will play a vital role in the startup of our high-volume production operations, working with a growing team! What will you do:Quality: Support the quality function respective to compliance and auditing; conduct quality inspections, such as dosimetry to ensure products meet established quality standards. Participate in audits to identify and implement quality improvements.Application Development: Evaluate customer requirements to determine if the product can be sterilized; define perform and document the qualification plan per ISO 13485 and ISO 11137.Order Release: Inspect orders, conduct dose measurements, compare with process parameters, perform batch release, handle internal deviations customer complaints, make root cause analysis.Equipment Oversight: Perform initial equipment qualification, monitoring, and release after maintenance activities. Responsible for all aspects of the dosimetry system, including dosimeter storage, calibration support, loading calibration curves, inventory monitoring, and controlling filter parameters (absorption, wavelength). Assist in qualification of equipment (IQ, OQ) for electron accelerators and manage qualifications following significant equipment spection Reports: Prepare detailed inspection reports and upload them to the customer order system, ensuring traceability of raw data for compliance and quality control.Customer Communication: Provide technical consulting to customers. Communicate with customers regarding quality issues in coordination with the sales team, manage special approvals, and resolve any document discrepancies or customer issues.Project Management and Process Development: Develop, plan, execute, complete, and document projects related to irradiation processes and parameters, ensuring successful outcomes. Coordinate with production and customers to manage schedules, experimental setups, and requirements for experimental irradiations and product qualifications.Qualifications and Requirements:Education: Bachelor's degree in engineering, quality, life sciences, or a related field.Experience: Several years of experience in applications engineering, quality assurance or a similar role in a regulated industry (e.g., ISO 13485, ISO 9001, AS 9100 D or similar) is required. Medical device industry experience is a strong plus.Field Knowledge: Familiarity with quality, radiation protection, safety and environmental requirements is preferred.Technical Skills: Strong understanding of processes, procedures, regulatory requirements, dosimetry, calibration processes, and equipment qualification.Analytical Skills: Ability to conduct thorough inspections, perform root cause analysis, evaluate experimental results, and prepare technical reports munication: Excellent communication skills, with proficiency in coordinating with internal departments and external customers.Software Proficiency: Proficiency in ERP systems and productionoffice software.Travel Ability: Training may include occasional travel internationally.This is a full-time position, with competitive pay commensurate with experience. Benefits available for a full-time position include health insurance, vision insurance, dental insurance, life and disability insurance, retirement savings plan with company match, paid time off, and training, educational and development programs.We are searching for exceptional team players to participate in a unique opportunity to build a company that offers best-in-class service to our customers. BSG US will offer the possibility to be cross trained in various capacities and to personally contribute to establishing the organization. We look forward to welcoming individuals with a positive attitude that want to be part of something special

Created: 2024-11-09