- 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
- 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.
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Manufacturing Support Technician - Coraopolis, United States - Krystal Biotech, Inc.
Description
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, VYJUVEKTM, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Located near Krystal's headquarters are two state-of-the-art GMP facilities.
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 patents
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:
Requirements and Preferred Qualifications:
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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