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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Perform routine cleaning and sanitization of processing equipment following established standard operating procedures.
Visually inspect manufacturing equipment to ensure integrity and that continues safe and in appropriate conditions for manufacturing purposes. Provide immediate awareness to supervisor of any issue. Handling, removal and disposal of hazardous materials.
Verify that the temperature, humidity and differential pressure of the clean rooms are within established parameters.
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 use and within expiration targets.
Perform the thawing, sampling, cleaning, weighing and dispensing of Collagen AT for the formulation of collagen dispersions.
Perform the calculations required to determine the amount of raw material needed for the formulation of lactic and/or collagen dispersions.
Sample and adjust pH during the formulation process according to the range established for the product.
Monitor 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 dispersion leveled at the trays.
Responsible for selecting the appropriate recipe at the lyophilization machine according to the product to be lyophilized.
Responsible of the lyophilization machine trays unloading, as well as the inspection and pack of the collagen sheets as per standard operating procedures.
Prepare the formaldehyde solution for the cross-linking of lyophilized sheets.
Responsible for making the appropriate connections of the cross-linking equipment as per standard operating procedures.
Perform the cross-linking of the lyophilized sheets maintaining product parameters as per standard operating procedures.
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.
Provide immediate awareness to supervisor of any safety risk, infra-structure damage, or conditions that may impact the appropriate execution of the manufacturing activities.
Perform inventory transaction as needed.
Contact QC Lab to coordinate the sampling and testing of materials. Deliver samples to QC Lab as needed.
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.
Associate degree in the science field (Chemistry, Biology etc.) or High School diploma or at least equivalent education.
Read English and follow written and verbal instructions.
Fundamental understanding of mathematics and chemistry
Basic mechanical skills are 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 and any shift.
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 complexities 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 required 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), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, and speak. The employee is required to go to all areas of the company. Must be able to perform tasks that may involve for extended periods of time standing, sitting, pushing, pulling, lifting, bending, kneeling, reaching, twisting, turning, climbing steps and lifting 30 - 60 pounds several times/hours a day. Ability to gown in Clean Room clothing. Work in wet and/or humid conditions Requires repetitive use of arms/wrist/hands while setting up/working with processing equipment throughout the day. Will require use of Personal Protective Equipment (PPE) and may include, but not limited to, safety glasses, safety shoes, lab coat, bouffant, gloves, hearing protection, face shield, nuisance mask, cartridge @type respirator. Must have good hand/eye coordination and visual acuity. Must be able to distinguish colors
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\veterans\employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
