Manufacturing Operator I - Collagen
Integra LifeSciences
Summary
This Clean Room Manufacturing Operator role will include processes such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion preparation, and lyophilization. It is essential to perform these tasks meticulously to ensure the quality of our products. Additionally, you will be responsible for the setup, operation, and cleaning of all clean room manufacturing equipment. This entails working in ISO Class 5 or ISO Class 7 areas and adhering to Clean Room gowning protocols. All operations must be conducted in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements. Operating in a team environment, we emphasize daily achievements and maintaining high-quality standards in our production processes.
Job description
Essential Duties and Responsibilities
- Writes labels for all materials, components, and products with identifying information such as Description, Quantity, Name, etc.
- Cuts collagen sponges to specific size using cutting equipment/tool.
- Inspects collagen products for defects, surface pattern, razor cuts, open edges, or foreign matter visually using the spot lights. Also inspect for thickness using the required measurement gage.
- Packs products as instructed in shop orders or procedures using Alloyd sealing machines.
- Reads shop orders, blueprints, and procedures for specifications.
- Fills information on the documentation such as Shop Orders, etc. as required.
- Assists group peers in order to complete assigned tasks.
- May perform other tasks as requested by supervisor.
- Assemblers are required to work on priority orders when released before others in order to meet production schedules.
- Assemblers are responsible for achieving established productivity levels and quality standards.
- Follows Clean Room Rules and Gowning Practices.
- Uses the required protective equipment of the assigned workstation.
- Follows Production Order Instructions and the established manufacturing specifications of Drawings, Procedures, and Shop Orders.
- Maintains work area and tools clean and organized at all moments.
Desired Minimum Qualifications
- High School diploma or equivalent. Degree in related science a plus.
- 0 - 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry.
- Production experience in a clean room environment is highly desirable.
- Basic computer skills for email and data entry.
- Must read, write and speak in English, and communicate clearly and concisely.
- Fundamental understanding of mathematics and chemistry.
- Able to participate in a team-oriented environment, willingness to assist and train others.
- Able to work independently with minimal supervision.
- Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed.
- Ability to gown to ISO Class 5 and 7 Clean Room standards.
- Able to work overtime.
Physical Requirements
- Must be able to stand for 8 hours, lift up to 60lbs and climb ladders without assistance.
- Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.
- Ability to gown to ISO Class 5 and/or ISO Class 7 Clean Room standards.
- Must be able to climb step ladders, without assistance.
- Vision: Requires eye sight correctable to 20/25 to detect any defect in product/materials. Requires normal color perception.
Requirements
- High School diploma or equivalent
- Degree in related science a plus
- 0 - 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry
- Production experience in a clean room environment is highly desirable
- Basic computer skills for email and data entry
- Must read, write and speak in English, and communicate clearly and concisely
- Fundamental understanding of mathematics and chemistry
- Able to participate in a team-oriented environment, willingness to assist and train others
- Able to work independently with minimal supervision
- Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed
- Ability to gown to ISO Class 5 and 7 Clean Room standards
- Able to work overtime
- Must be able to stand for 8 hours, lift up to 60lbs and climb ladders without assistance
- Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis
- Vision correctable to 20/25 and normal color perception
Benefits
- Medical, Dental & Vision
- Life Insurance
- Short- & Long-Term Disability
- Business Accident Insurance
- Group Legal Insurance
- 401(k) Savings Plan
Company overview
Integra LifeSciences Holdings Corporation is a global medical technology company headquartered in Princeton, New Jersey, founded in 1989. As a publicly traded company on NASDAQ under the symbol IART, Integra specializes in developing and manufacturing innovative medical devices for neurosurgery, reconstructive surgery, and general surgery applications. The company is renowned for its pioneering work in regenerative medicine, most notably the Integra artificial skin, which was the first commercially reproducible skin tissue used to treat severe burns and other skin wounds. Integra's comprehensive product portfolio includes surgical instruments, neurosurgical devices, advanced wound care solutions, orthopedic hardware, dermal regeneration products, and tissue-engineered wound dressings. With approximately 3,946-4,396 employees worldwide, the company serves hospitals, outpatient surgery centers, and medical practices globally through direct sales representatives and an extensive distribution network. Integra's commitment to limiting uncertainty for surgeons enables healthcare professionals to focus on providing optimal patient care through simplified procedures and reliable medical technology solutions.