Sterilization Process Specialist
1 week ago
BGS US, a leading services provider of beta rays for radiation sterilization, is seeking an experienced professional to staff our US-based operations with immediate opportunity at our new production facility in Imperial, PA. The successful candidate will play a vital role in the startup of our high-volume production operations, working closely with our growing team.
Key Responsibilities:
- Sterilization Process Development: Evaluate customer requirements to determine if products can be sterilized using our radiation processes. Develop and execute validation projects related to irradiation processes and parameters, ensuring compliance with regulatory requirements.
- Order Release and Quality Control: Inspect orders, conduct dose measurements, compare with process parameters, and perform batch release. Handle internal deviations and customer complaints, making root cause analysis.
- Technical Reporting and Communication: Prepare detailed reports on sterilization processes and upload them to our ERP system. Ensure traceability of data for compliance and quality control purposes. Provide technical consulting to customers, communicating quality issues with our sales team and resolving document discrepancies or customer concerns.
- Equipment Oversight and Maintenance: Perform initial equipment qualification, monitoring, and release after maintenance activities. Oversee all aspects of the dosimetry system, including dosimeter storage, calibration support, loading calibration curves, inventory monitoring, and controlling filter parameters (absorption, wavelength).
- Quality Support and Improvement: Support the quality function by preparing validation protocols and conducting quality inspections. Assist with audits and the 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 of experience in applications engineering, quality assurance, or a similar role. Preference for regulated industries (e.g., ISO 13485, ISO 9001, AS 9100 D) and medical device industry experience.
- Field Knowledge: Familiarity with quality, radiation protection, safety, and environmental requirements is preferred but not required.
- Technical Skills: Understanding processes, procedures, regulatory requirements, dosimetry, and/or calibration processes is helpful.
- Analytical Skills: Ability to conduct thorough inspections, perform root cause analysis, evaluate experimental results, and prepare technical reports accurately.
- Communication: Excellent communication skills, 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 international travel.
This is a full-time position, with a competitive salary range of $80,000 - $110,000 per year, 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.
BGS US is searching for exceptional team players to participate in a unique opportunity to build a company that offers best-in-class service to our customers. We look forward to welcoming individuals with a positive attitude who want to be part of something special.
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