Manufacturing Technician (Sterilization Technician)

Sterilization Technician

The incumbent will be responsible for performing production duties in the Chemical Sterilization areas (clean rooms) in accordance with good manufacturing practice and established standard operating procedures.

Key Responsibilities:

• Chemically sterilize and aseptically transfer bioprosthetic heart valves according to prescribed procedures and techniques
• Assemble/disassemble and monitor process equipment used for the sterilization of bioprosthetic heart valves.
• Clean and sterilize glassware, instruments, carboys and other equipment.
• Operate, clean, and maintain production equipment and devices by following written procedures.
• Assure equipment has been calibrated and is in acceptable working condition prior to use; reporting issues promptly.
• Maintain traceability and proper documentation on all materials and components processed in the area.
• Document work accurately and completely in the Manufacturing Execution System (MES), BPCS Business System, forms or logbooks/daily production logs as applicable
• Perform cleaning of critical manufacturing room and gowning areas in accordance with established procedures
• Handle chemicals in a safe manner following procedures.
• Perform other duties as required

Knowledge, Skills, and Abilities:

• Knowledge of aseptic technique is desired
• Mechanical aptitude with good manual dexterity and ability to do repetitive detailed work within guidelines
• Proficient written and verbal communication skills to follow procedures written in English and to maintain precise records.
• Open minded and accepts constructive criticism and feedback
• Ability to work well with co-workers in a team environment with limited supervision.
• Relevant experience with equipment process control systems ( HMI/PLC)
• Experience with Microsoft Office Suite applications (Word, Excel, Outlook).
• Must carry valid drivers' license and vehicle.

Education and Experience:

• Technical Diploma or degree in relevant area.