Custodian / Cleanroom Facility Support - Krystal Biotech
Pittsburgh, PA 15203
About the Job
About Krystal Bio:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline.
Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additional offices are situated in Boston, MA and in Zug, Switzerland.
Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patients!
Job Description Summary:
Krystal Biotech, Inc is currently seeking a dedicated Technician to join our dynamic team. This role involves ensuring our products are packaged in compliance with FDA regulations and established protocols. The ideal Technician will provide a constant focus on integrity, safety, and quality for our patients while upholding cleanroom standards in a highly regulated setting.
Primary Responsibilities:
Requirements and Desired Qualifications:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline.
Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additional offices are situated in Boston, MA and in Zug, Switzerland.
Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patients!
Job Description Summary:
Krystal Biotech, Inc is currently seeking a dedicated Technician to join our dynamic team. This role involves ensuring our products are packaged in compliance with FDA regulations and established protocols. The ideal Technician will provide a constant focus on integrity, safety, and quality for our patients while upholding cleanroom standards in a highly regulated setting.
Primary Responsibilities:
- Uphold cleanroom standards and provide regular support with cleaning / sanitization efforts within the suite.
- Maintain a clean and organized work environment, ensuring compliance with Good Manufacturing Practices (GMP).
- Adhere to FDA guidelines and internal standard operating procedures (SOPs) in all activities.
- Document and maintain accurate records of activities.
- Participate in continuous improvement initiatives to enhance efficiency, safety, and quality.
- Collaborate with cross-functional teams to ensure smooth production operations.
- Address and resolve any issues or concerns related to cleanroom operation.
- Participate in training programs and stay updated on new equipment, technologies, and processes.
Requirements and Desired Qualifications:
- Associate’s degree in a relevant field or equivalent work experience.
- Previous experience in a regulated environment, ideally in a pharmaceutical/biotech setting.
- Familiarity with FDA regulations, GMP, and other relevant industry standards, is preferred.
- Background in cleanroom / aseptic environments highly preferred.
- Excellent problem-solving and troubleshooting skills.
- Ability to work in a fast-paced environment and handle multiple tasks concurrently.
- Strong written and verbal communication skills.
- A team player with a proactive attitude.
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Source : Krystal Biotech