Descripción del Trabajo
Jabil Brandywine’s diverse capabilities help our customers succeed in the complex, evolving healthcare marketplace.
Located in the township of West Chester, PA, just 30 miles southwest of Philadelphia, Jabil Brandywine produces a broad portfolio of products for the trauma and spine markets, as well as minimally invasive surgical procedures. Additionally, patient-specific orthopedic plates and implant products manufactured on site are shipped directly to hospitals.
The Junior Microbiologist will assist with the implementation and support of Environmental Monitoring (EM) and contamination control at the Manufacturing site in compliance with US FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001.
POSITION DUTIES & RESPONSIBILITIES:
Provide biological and chemical testing support to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness at the manufacturing facilities.
Work closely with the Manufacturing and Quality groups to establish and maintain procedures, tools and methodologies related to the EM and product testing programs.
Maintain knowledge of FDA and ISO EM guidelines, as applicable.
Implement and responsibly execute routine sterilization and microbiological programs.
Conduct technical assessments of contract laboratories.
Provide guidance and training to personnel to ensure biological and chemical program requirements are met.
Provide assistance for monitoring controlled environments, process water quality and product cleanliness.
Provide assistance with validating cleanrooms and sterilization processes.
Provide training to plant personnel for cleanroom activities, as required.
Know and follow all laws and policies that apply to the position, and maintain the highest levels of professionalism, ethics and compliance at all times.
Diligently participate in compliance program-related activities.
Other duties/responsibilities as assigned by manager.
EDUCATION & EXPERIENCE REQUIREMENTS:
A minimum of a Bachelor's degree (focus on Microbiology, Biological Science, or Engineering is preferred). Industry experience in medical device and /or pharmaceutical is highly preferred. Experience with microbiological testing and water testing is preferred.
Strict attention to detail.
Must be able to work in an open office environment.
Must be able to work under pressure due to reporting deadlines.
Strong written and oral communication, organization, and time-managements skills are required.
Excellent knowledge of English language
Basic understanding of chemistry and microbiology.