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Company | Krystal Biotech, Inc. |
Address | Moon, PA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet Publishing |
Expires | 2023-07-29 |
Posted at | 10 months ago |
About Krystal Bio:
- Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule
- 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
- Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner
- Support the maintenance of process gas levels, calibration of equipment, and preventative maintenance schedules
- Adhere to safety protocols and guidelines, including proper handling and disposal of hazardous waste materials
- Conduct routine inspections of cleanrooms to identify any cleanliness or contamination issues, promptly reporting and addressing them according to established procedures
- Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs
- Execute and maintain strict cleaning and sanitization protocols in compliance with current Good Manufacturing Practices (cGMP) guidelines and Standard Operating Procedures (SOPs)
- Perform other tasks, as assigned
- In lieu of direct experience, bachelor’s degrees in applicable fields such as life sciences or engineering will be considered
- 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
- High school diploma or equivalent is required; additional technical or vocational training in biopharma manufacturing, cleanroom operations, or related fields is a plus
- Physical stamina and the ability to stand, bend, and lift heavy objects when necessary
- Experience with sanitization, aseptic technique and/or sterile processes in a regulated setting (GMP, ISO) is highly preferred
- Excellent communication and the ability to work well both independently and as part of a team
- Ability to follow detailed instructions and maintain accurate documentation
- Flexibility to work shifts, including evenings, weekends, and holidays as required.
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