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Clean Room Manufacturing Operator (2nd Shift)

Overview
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Responsibilities
Performs post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, and labeling and boxing in order to produce the finished good. Also performs sub assemble post chemical processing such as cross linking required to produce collagen-based products. All work streams include responsibility in the setup, operation and cleaning of all clean room manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Clean Room gowning. All processing is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations), Standard Operating Procedures (SOP's) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughput.
Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and be able to make minor equipment adjustments as needed.
Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
Responsible for the cross linking, cutting, packaging and boxing of the product in its finished goods form, which includes performing visual product and component inspections to identify and remove defects.
Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety requirements.
Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
Enter and record production activies in Oracle MRP systems to issue material and labor hours to specific work orders.
Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.
Responsible for reporting all discrepancies to the Supervisor or Group Leader.
Support department and plant Safety goals by continuously demonstrating safe behavior.
Maintain a clean and orderly work area
Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements
Perform other manufacturing activities as assigned by the department leadership
Qualifications
High School diploma or equivalent. Degree in related science a plus.
1 to 5 years of clean room experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry.
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 is a plus.
Able to work overtime
TOOLS AND EQUIPMENT USED
Lyophilizers, Autoclave, homogenizers, grinder, vacuum pump, pH meters, thermometers, balances (scales), water bath circulators, sonicators, humidity cabinet, mixers, centrifuge, blenders, air gun, drop indicator, Filamatic filling machines, slicer machines, scalpels, temperature recorders, Crosslinking chamber, humidification chamber, compression unit, cutting table, sealing machines, shrink wrap machines.
PHYSICAL REQUIREMENTS
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee must be able to stand for 8 hours, lift up to 60lbs and climb ladders without assistance. The employee is required to go to all areas of the company.
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), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.
Ability to gown to ISO Class 5 type Clean Room standards and/or additional Clean room clothing
Ability to gown to ISO Class 7 type Clean Room standards and/or additional Clean room clothing
Ability to stand for 8 hours
Must be able to climb step ladders, without assistance
Vision: Requires eye sight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all of the quality reclassification. Requires normal color perception. The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment. Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.
ADVERSE WORKING CONDITIONS
Daily interaction with hazardous materials used in a controlled environment.



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