BGS, a leading services provider of beta rays for radiation sterilization, is currently staffing US-based operations with immediate opportunity at our new production facility in Imperial, PA.
We are seeking an enthusiastic and safety-oriented Validation Technician with technical aptitude. 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:
Application and Process Development: Evaluate customer requirements to determine if the product can be sterilized. Develop, plan, execute, complete, and document validation projects related to irradiation processes and parameters. Coordinate with production and customers to manage schedules, experimental setups, and requirements for experimental irradiations and product qualifications.
Order Release: Inspect orders, conduct dose measurements, compare with process parameters, perform batch release, handle internal deviations / customer complaints, make root cause analysis.
Validation Reports: Prepare detailed reports and upload them to the ERP system, ensuring traceability of 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.
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).
Quality: Support the quality function by preparing validation protocols and conducting quality inspections. Assist with audits and the resulting identification and implementation of quality improvements.
Qualifications and Requirements:
Education: Bachelor's or technical degree in engineering, quality, life sciences, or equivalent / related field experience.
Experience: Several years experience in applications engineering, quality assurance or a similar role. Preference to 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 but not required.
Analytical Skills: Ability to conduct thorough inspections, perform root cause analysis, evaluate experimental results, and prepare technical reports accurately.
Communication: Excellent communication skills, with proficiency in coordinating with internal departments and external customers.
Software Proficiency: Proficiency in ERP systems and production/office 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.