Cleanroom / Environmental Monitoring Technician

Cleanroom Environmental Monitoring Technician

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on Twitter and LinkedIn.

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Cleanroom 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 growing 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

Requirements and Preferred Qualifications:

• Bachelor’s Degree (Biology or related Life Science) with 1+ years of experience in microbiology (preferably including culture maintenance) or 3+ years of experience in environmental monitoring
• 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 skills
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Must be able to handle multiple roles and have the ability to strive in a fast-paced, creative, and goal-oriented environment and know how to prioritize activities appropriately

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc.  will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

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