Manufacturing Support Technician - Krystal Biotech : Job Details

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 Manufacturing Support Technician to support a new state-of-the-art GMP facility in Moon Township. The Technician will work closely with the manufacturing team to uphold cleanroom standards, follow strict procedures, and contribute to the smooth operation of all manufacturing processes.Primary Responsibilities:Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs.Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule.Execute and maintain strict cleaning and sanitization protocols in compliance with current Good Manufacturing Practices (cGMP) guidelines and Standard Operating Procedures (SOPs).Conduct routine inspections of cleanrooms to identify any cleanliness or contamination issues, promptly reporting and addressing them according to established procedures.Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner.Adhere to safety protocols and guidelines, including proper handling and disposal of hazardous waste materials.Support the maintenance of process gas levels, calibration of equipment, and preventative maintenance schedules.Participate in training sessions and meetings to stay updated on the latest industry standards, regulations, and best practices.Assist with movement of materials; work with EHS/Materials Teams for collection and dispensing of biohazardous waste.Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends.Perform other tasks, as assigned.Requirements and Preferred Qualifications:High school diploma or equivalent is required; additional technical or vocational training in biopharma manufacturing, cleanroom operations, or related fields is a plus.In lieu of direct experience, bachelor's degrees in applicable fields such as life sciences or engineering will be considered.Experience with sanitization, aseptic technique and/or sterile processes in a regulated setting (GMP, ISO) is highly preferred.Ability to follow detailed instructions and maintain accurate documentation.Excellent attention to detail, organization skills, and the ability to prioritize and multitask effectively in a fast-paced environment.Demonstrated commitment to safety protocols and adherence to standard operating procedures.Excellent communication and the ability to work well both independently and as part of a team.Physical stamina and the ability to stand, bend, and lift heavy objects when necessary.Flexibility to work shifts, including evenings, weekends, and holidays as required.Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. 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.#J-18808-Ljbffr