Manufacturing Operator II

Integra LifeSciences•Plainsboro Township, NJ

1d•Onsite

About The Position

This role performs post-formulation processing, including product cutting, inspection, defect identification, packaging, machine packaging operations, labeling, and boxing to produce finished goods. It also involves sub-assembly post-chemical processing, such as cross-linking for collagen-based products. Responsibilities include the setup, operation, and cleaning of cleanroom manufacturing equipment in ISO Class 5 or ISO Class 7 areas, requiring proper cleanroom gowning. All processing must comply with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements. The role operates in a team environment focused on daily milestones and quality. The shift is Monday - Thursday, 1st shift, 10-hour days. The operator will operate, maintain, and troubleshoot process equipment, perform precise measurements, and use measurement equipment for chemical additions. They will be responsible for the cross-linking, cutting, packaging, and boxing of the product, including visual inspections for defects. Maintaining gowning qualification for ISO Class 5 and 7 cleanrooms is essential. Accurate record-keeping, including logs and procedures, is required to comply with regulatory standards. The role involves interfacing with QA/QC/Material departments and entering production activities into Oracle MRP systems. Adherence to SOPs, Quality System Regulations, and ISO 13485 requirements is mandatory.

Requirements

High School diploma or equivalent.
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.
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.
Ability to stand for 8 hours.
Must be able to bend and lift 30 to 60 lbs without assistance daily.
Vision: Requires eyesight correctable to 20/25 to detect any defect in product/materials.
Visual acuity adequate to perform job duties, including meeting all of quality reclassification.
Requires normal color perception.

Nice To Haves

Degree in a related science a plus.
Production experience is highly desirable.
Able to work overtime.
Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements.
Ability to climb step ladders without assistance.

Responsibilities

Performs post-formulation processing such as product cutting, inspection, defect identification, packaging, machine packaging operations, and labeling and boxing to produce the finished good.
Performs sub-assembly post chemical processing such as cross linking required to produce collagen-based products.
Responsible for the setup, operation, and cleaning of all clean room manufacturing equipment.
Operates, maintains, and troubleshoots process equipment utilized in the collagen business, and makes 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.
Interfaces with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
Enters and records production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
Follows applicable Standard Operating Procedures, Quality System Regulations, and ISO 13485 requirements.
Supports department and plant Safety goals by continuously demonstrating safe behavior.
Maintains a clean and orderly work area.
Performs other manufacturing activities as assigned by the department leadership.