Clean Room Manufacturing Specialist

3 days ago


Plainsboro, New Jersey, United States Integra LifeSciences Full time
Job Summary

We are seeking a highly skilled and detail-oriented Clean Room Manufacturing Operator to join our team at Integra LifeSciences. As a key member of our production team, you will be responsible for ensuring the accurate and efficient processing of medical devices in a clean room environment.

Key Responsibilities
  • Verify and record all incoming and outgoing shipments, ensuring accurate inventory levels and compliance with regulatory requirements.
  • Perform physical inventory movements, including receiving, storing, and distributing materials to various locations within the facility.
  • Operate and maintain process equipment, including lyophilizers, autoclaves, and homogenizers, to ensure optimal performance and compliance with Good Manufacturing Practices (GMPs).
  • Conduct visual product and component inspections to identify and remove defects, ensuring the highest quality standards are met.
  • Collaborate with internal and external teams to ensure timely and accurate processing of shipments, including coordinating with QA/QC and Material departments.
  • Enter and record production activities in Oracle MRP systems, ensuring accurate tracking and reporting of material and labor hours.
  • Follow applicable Standard Operating Procedures (SOPs), Quality System Regulations, and ISO 13485 requirements to ensure compliance and adherence to regulatory standards.
Requirements
  • High School diploma or equivalent required; degree in a related science a plus.
  • 0-2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry.
  • Basic computer skills for email and data entry.
  • Ability to read, write, and speak 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 flexible shifts, and flexible days within the week to meet batch milestone requirements.
Working Conditions

The Clean Room Manufacturing Operator will work in a general plant environment, with potential exposure to hazardous and Biohazardous materials, including flammable and corrosive liquids, compressed gases, and medical wastes.

Integra LifeSciences is an equal opportunity employer, 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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