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The Cleanroom Manufacturing Operator will perform initial chemical processing and batch mixing such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion prep and lyophilization required to produce collagen-based products. Performs the set up, and operates all clean room manufacturing equipment. 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES - to perform this job successfully, an individual must be able to perform each essential duty satisfactory.

• 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.

• Blend, mix, pour, and load collagen prepped material into lyophilizing equipment.

• 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 activities 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

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• 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 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

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

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.

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.

• Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.

• Ability to gown to ISO Class 5 Clean Room standards and/or additional Clean room clothing

• Ability to gown to ISO Class 7 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.

ADVERSE WORKING CONDITIONS

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.

• Daily interaction with hazardous materials used in a controlled environment.

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/laws/index.cfm) | 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 or call us at 855-936-2666.

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