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This Clean Room Manufacturing Operator will perform post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, labeling, and boxing in order to produce the finished good. Also performs sub assembly post chemical processing such as crosslinking required to produce collagen-based products. All work streams include responsibility in the setup, operation and cleaning of all cleanroom manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Cleanroom 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 throughout.
Essential Duties and Responsibilities
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 crosslinking, 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 cleanroom operations or ISO Class 7 cleanroom 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 Management 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.
Desired Minimum Qualifications
High School diploma or equivalent. Degree in a 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.
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.
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.
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.
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.
Must be able to climb step ladders without assistance.
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.
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