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Manufacturing Operations Specialist
2 months ago
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.
Key Responsibilities- Facility Preparation: Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs.
- Collaboration and Communication: Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule.
- Cleaning and Sanitization: Execute and maintain strict cleaning and sanitization protocols in compliance with current Good Manufacturing Practices (cGMP) guidelines and Standard Operating Procedures (SOPs).
- Quality Control: Conduct routine inspections of cleanrooms to identify any cleanliness or contamination issues, promptly reporting and addressing them according to established procedures.
- Documentation and Record-Keeping: Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner.
- Safety Protocols: Adhere to safety protocols and guidelines, including proper handling and disposal of hazardous waste materials.
- Maintenance and Calibration: Support the maintenance of process gas levels, calibration of equipment, and preventative maintenance schedules.
- Training and Development: Participate in training sessions and meetings to stay updated on the latest industry standards, regulations, and best practices.
- Material Handling: Assist with movement of materials; work with EHS/Materials Teams for collection and dispensing of biohazardous waste.
- Flexibility and Adaptability: Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends.
- Education: High school diploma or equivalent is required; additional technical or vocational training in biopharma manufacturing, cleanroom operations, or related fields is a plus.
- Experience: In lieu of direct experience, bachelor's degrees in applicable fields such as life sciences or engineering will be considered.
- Sanitization and Aseptic Technique: Experience with sanitization, aseptic technique and/or sterile processes in a regulated setting (GMP, ISO) is highly preferred.
- Attention to Detail and Organization: Ability to follow detailed instructions and maintain accurate documentation.
- Communication and Teamwork: Excellent communication and the ability to work well both independently and as part of a team.
- Physical Demands: Physical stamina and the ability to stand, bend, and lift heavy objects when necessary.
- Flexibility: Flexibility to work shifts, including evenings, weekends, and holidays as required.
