Clean Room Chemical Operator

Changing lives. Building Careers.

Joining us is a chance for you 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, more than 4,000 of us are challenging whats possible and making headway to help improve outcomes.

SUMMARY DESCRIPTION

Performs post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, and labeling and boxing 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 (SOPs) 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 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 (SOPs), 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.

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

The employee must be able to stand for 8 hours, lift to 60lbs

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.

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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