Clean Room Manufacturing Operator 2

Integra LifeSciences•Plainsboro Township, NJ

1d•$21 - $28•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 II will perform pre and post-formulation processing such as blending, mixing, pouring, loading, 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 for 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 (QSR), Standard Operating Procedures (SOP’s) and Health and Safety requirements. Operate in a team environment focused on daily milestones and quality throughout. This is a first shift (7:00 a.m. - 3:30 p.m.), Monday through Friday role. • Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and can make minor equipment adjustments as needed. • Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches. • Blend, mix, pour, and load collagen prepped material into lyophilizing equipment. • 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, 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. • Responsible for handling, decontamination, and cleaning of production supplies, instruments, and equipment to support all cleanroom production related activities • Responsible for reporting all discrepancies to the Supervisor or Group Leader. • Support department and plant Safety goals by continuously demonstrating safe behavior. • Support training as required by the department management. • Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements. DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. • High School diploma or equivalent. Degree in related science a plus. • 2+ years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry. Production experience in a clean room environment 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

Requirements

High School diploma or equivalent.
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
Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.
Ability to gown to ISO Class 5 Clean Room standards and/or additional Clean room clothing
Ability to gown to ISO Class 7 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 eye sight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all the quality reclassification. Requires normal color perception.

Nice To Haves

Degree in related science a plus.
Production experience in a clean room environment is highly desirable.

Responsibilities

Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and can make minor equipment adjustments as needed.
Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
Blend, mix, pour, and load collagen prepped material into lyophilizing equipment.
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, 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.
Responsible for handling, decontamination, and cleaning of production supplies, instruments, and equipment to support all cleanroom production related activities
Responsible for reporting all discrepancies to the Supervisor or Group Leader.
Support department and plant Safety goals by continuously demonstrating safe behavior.
Support training as required by the department management.
Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements.