Senior Manufacturing Operator, 1st Shift M-Th 10Hrs

Integra LifeSciences•Plainsboro Township, NJ

1d•Onsite

About The Position

The Senior Manufacturing Operator is responsible for post-formulation processing, including product cutting, inspection, defect identification, packaging, machine packaging operations, labeling, and boxing to produce finished goods. The role also involves sub-assembly post-chemical processing, such as crosslinking for collagen-based products. Key responsibilities include the setup, operation, and cleaning of all cleanroom manufacturing equipment. All chemical processing operations are conducted in ISO Class 5 or ISO Class 7 areas, necessitating proper Cleanroom gowning. All tasks must adhere to Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements. The operator works within a team environment, focusing on daily milestones and maintaining quality throughout the production process.

Requirements

High School diploma or equivalent.
A minimum of 5 years of production experience and/or chemical processing experience and/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 cleanroom standards.
Able to work overtime.
Requires proficiency through job-related training and considerable on the job experience.

Nice To Haves

Degree in a related science a plus.

Responsibilities

Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and be able to make minor equipment adjustments as needed.
Subject Matter expert on processes and procedures.
Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
Responsible for the crosslinking, 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 cleanroom operations or ISO Class 7 cleanroom 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 Management 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.
Responsible to work with the area Supervisor, Lead Operator, and/or Training Lead to regularly train colleagues with less experience.
Follow applicable Standard Operating Procedures, Quality System Regulations, and ISO 13485 requirements.
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.
May act as an informal resource for colleagues with less experience.