Starting Pay

$18.00/hour

Job Summary

A Manufacturing Technician I is part of the team responsible for the manufacturing and packaging of medical devices in a cleanroom environment. As a Manufacturing Technician I, you will be primarily responsible for high volume cutting, milling, and packaging of natural polymer devices used in wound care applications.

Responsibilities (Essential Duties and Responsibilities):

• Sizing product by processing it with die cutters and powder milling equipment.
• Packaging product into sterile barrier packaging. This includes filling jars, tubes, and pouches. Sealing pouches, labeling pouches, assembly into boxes and labeling boxes.
• Printing product labels using barcode label software and a label printer.
• Performing measurements of length, thickness, mass, volume, torque, and pH.
• Mixing both dry and liquid chemicals as directed by standard work instructions.
• Documenting work performed in batch records as directed by standard work instructions.
• Collecting samples of products for quality assurance purposes.
• Setup, operation, monitoring, and teardown of mixing equipment, filling equipment, cutting presses, milling equipment, heat sealers, and other packaging equipment.
• Cleaning and disinfecting equipment and supplies used in the manufacture of product.
• Comply with FDA Good Manufacturing Practices and Good Documentation Practices.
• Promote and enforce a safe working environment by adhering to OSHA regulations and company safety policies.

Responsibilities (Non-Essential Duties and Responsibilities):

• Regular cleaning and disinfection of the cleanroom areas.
• Picking raw materials from inventory locations.
• Identifying raw material shortages and issues.
• Identify, label, and properly store hazardous waste.

Minimum Required Qualifications (Knowledge, Skills, and Abilities):

• High School diploma or GED
• The ability to count and to perform basic math calculations such as addition, subtraction, and evaluation of greater-than or less-than scenarios.
• The ability to add, subtract, and evaluate time in 24-hour (military) format.
• Good verbal communication skills.
• Legible handwriting for recording data in manufacturing records.
  

Preferred Qualifications (Knowledge, Skills, and Abilities):

• 2-year technology degree in biotechnology or another scientific field
• Experience working in a cleanroom environment.
• Experience in the medical device or pharmaceutical industry working with Good Manufacturing Practices (GMP).
• Experience measuring length, thickness, mass, volume, and pH.
• Familiarity with FDA regulations, ISO standards, and Quality Management Systems.

Language Skills:

• Candidate must have the ability to proficiently read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations written in the English language. Must also be able to effectively present information and respond to questions from groups of managers, clients, customers, and the general public in the English language.

Work Environment:

• Most of the individual’s time will be spent in an air-conditioned cleanroom environment. Lesser amounts of time will be spent in the warehouse. Functions will be performed in both a sitting and standing position. When in the cleanroom, the individual will be expected to wear designated gowning and follow standard anti-contamination practices.

Physical Demands:

• Bending, lifting, pulling, pushing, and standing for long periods of time.
• Measurement, assembly, and paper documentation activities requiring manual dexterity.
• Move containers and boxes weighing up to 50 pounds on occasion.
• Cleaning (mopping and wiping) of cleanrooms and the equipment contained within them.