Job Description
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Manufacturing Operator I -Lyo is responsible for cutting, inspection, packaging and boxing operations on Collagen assembly line using required equipment and hand tools . May be assigned to different work stations as production needs require. Works on line where tasks vary as different models of products moves to be assembled. Reports to the Manufacturing Superintendent through the Cell or Group Leader of the area. ESSENTIAL DUTIES AND RESPONSIBILITIES Perform routine cleaning and sanitation of processing equipment following established standard operating procedures. Handling, removal and disposal of hazardous materials. Setup and operate equipment of different complexity such as scales, pH meters, mixing tanks, mixers, shakers, homogenization equipment, lyophilization machines and formaldehyde cross-linking chamber. Verify that all material is approved for usage Responsible of the thawing, sampling, cleaning, weighing and dispensing of Collagen AT for the formulation of collagen dispersion. Perform the calculations required to determine the amount of raw material needed for the formulation of lactic and/or collagen dispersion. Adjust pH during the formulation process according to the range established for the product. Monitors meters, gauges, temperatures, pressures, and related controls. Perform required adjustments (ex: temperature, pressure) as per-standard procedures. Responsible for the pouring and leveling of dispersion in trays following a specific technique. Load the lyophilization machine while maintaining the leveling of dispersion at the trays. Responsible for selecting the appropriate recipe at the lyophilization machine according to the product to be lyophilized. Unload the lyophilization machine; inspect and pack the sheets as per-standard operating procedures. Prepare the formaldehyde solution for the cross-linking of lyophilized sheets. Perform the cross-linking of the lyophilized sheets according to the product parameters. Perform periodic evaluation of the trays to ensure flatness and integrity. Support inventory counting activities as required. Responsible for ensuring timely and accurate documentation of all manufacturing activities performed as well as any other production /regulatory logs or records. Responsible for maintaining work areas in order, clean and according to EHS requirements. Perform inventory transaction as needed. Contact QC lab to coordinate the sampling and testing of materials. Propose revisions to standard operating procedures. Performs other activities as required by the supervisor. DESIRED MINIMUM QUALIFICATIONS – Education and Experience The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. High School diploma or equivalent. Associate degree in the science field (Preferred) Read English and follow written and verbal instructions Fundamental understanding of mathematics and chemistry Basic mechanical skills is a plus Willingness to learn, ability to adapt to change and a positive attitude Demonstrate safe behavior and support department/plant Safety goals in a continuous improvement process. Possess the ability to participate in a team-oriented environment, willingness to assist and train others, flexible and able to work overtime. • Make effective use of work time; be self-starter and work independently when necessary. • Recognize the importance of punctuality and good attendance. Must be able to follow the policies set forth by Integra. Willing to travel out of the country. TOOLS AND EQUIPMENT USED • General office equipment including, printers, copiers, scanners, and fax machines. • Equipment of different complexity such as scales, pH meters, mixing tanks, mixers, shakers, homogenization equipment, vacuum pumps, temperature recorders, lyophilization machines and formaldehyde cross-linking chamber. PHYSICAL REQUIREMENTS The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA)