Manufacturing Operator II

Integra LifeSciences•Plainsboro Township, NJ

1d•Onsite

About The Position

Changing lives. Building Careers. Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Manufacturing Operator level II 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 (SOP’s) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughout. Shift works Monday - Thursday 1st shift, 10 hour days Performs 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 throughout. Blend, mix, pour, and load collagen prepped material into lyophilizing chambers. 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 (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.

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.
Able to work overtime.
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.
Ability to stand for 8 hours.
Must be able to climb step ladders without assistance.
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.
Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements.

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 assemble post chemical processing such as cross linking required to produce collagen-based products.
Performs the setup, operation, and cleaning of all clean room manufacturing equipment.
Blends, mixes, pours, and loads collagen prepped material into lyophilizing chambers.
Operates, maintains, and troubleshoots process equipment utilized in the collagen business, and makes minor equipment adjustments as needed.
Performs precise measurements and uses measurement equipment to accurately add chemicals to batches.
Performs 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.
Passes and maintains gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
Accurately maintains 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.