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QC Microbiology Technician (Cleanroom)
Krystal BiotechPittsburgh, United Statesfull_timeVerifiedPosted 5 Dec 2024
About the role
About Krystal Bio:
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated QC Environmental Monitoring Technician to drive and sustain a comprehensive Cleanroom Environmental Monitoring Program that ensures regulatory compliance and promotes a strong culture of environmental cleanliness. This role will support the EM Department in sample collection and laboratory analysis.
Primary Responsibilities:
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated QC Environmental Monitoring Technician to drive and sustain a comprehensive Cleanroom Environmental Monitoring Program that ensures regulatory compliance and promotes a strong culture of environmental cleanliness. This role will support the EM Department in sample collection and laboratory analysis.
Primary Responsibilities:
- Perform routine and ad-hoc environmental sampling consisting of active viable air, non-viable air, and viable surface following a detailed sampling plan
- Help manage environmental programs in viable & non-viable air particulates and surface organisms
- Participate in development, validation, and management of environmental monitoring and water testing program
- Maintain accurate and detailed documentation according to regulatory guidelines associated with sampling events
- Write and review technical, data driven, reports
- Perform data entry and identify trends in real-time
- Operate and maintain sampling and laboratory equipment
- Initiate and support investigation for out of specification results including definitive root cause analysis
- Develop and execute SOP’s and maintain compliance
- Assist with monitoring and reporting Environmental key performance indicators (KPI's); Analyze and trend results, perform statistical evaluations of KPI’s, and present to team
- Physical Attributes: This job will involve standing/walking for extended periods and lifting up to 25lbs
- Other duties as assigned
- Bachelor’s Degree (Biology or related Life Science) with 1+ years of experience in microbiology (preferably including culture maintenance) or 3+ years of experience working in environmental monitoring program
- Prior experience working in a classified clean room is desired
- Background in GMP and/or GLP environments
- Aseptic technique and the ability to gown into a sterile environment
- Self-starter and capable of working with minimal oversight
- Excellent oral and written communication
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