QC Microbiology Technician (Cleanroom)

QC Microbiology Technician (Cleanroom)

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 Quality Control 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 assignedRequirements 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 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 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.