Lead Operator - 1st Shift

Integra LifeSciences; New Jersey; On-site; USD 65,000 - 90,000; Full time

Job summary

6AM City, LLC is seeking a Clean Room Manufacturing Lead Operator in New Jersey to oversee enzymatic and alkali collagen processing, tendon prep, dispersion and lyophilization. You will ensure GMP compliance, ISO cleanroom protocols, and meticulous documentation in batch records.

In a team environment, you will train operators, lead troubleshooting, manage inventories, and coordinate start/stop times while maintaining high quality standards and safety across ISO classes.

Qualifications

• High School diploma or equivalent; science-related degree preferred.
• 3-5 years of chemical processing or batch mixing in medical device/pharma manufacturing.
• Basic computer skills for email and data entry.
• Must read, write and speak English clearly.
• Fundamental understanding of mathematics and chemistry.
• Able to work in a team and train others.
• Able to work overtime.

Responsibilities

• Allocate resources to meet daily schedule needs and support plan development.
• Provide daily oversight of medical manufacturing operations.
• Lead troubleshooting to minimize downtime.
• Identify equipment deficiencies and observe operator performance.
• Support investigations as a subject matter expert.
• Maintain process and component inventories.
• Document batch records and ensure timely completion of tasks.

Skills

English (read/write/speak)

Teamwork

Independent work

Math & Chemistry

Education

High School diploma or equivalent

Science-related degree

Tools

Lyophilizers

Homogenizers

Tornado Mill

Vacuum pump

pH meters

Thermometers

Balances

Job description

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.

SUMMARY DESCRIPTION

This Clean Room Manufacturing Lead Operator role will include processes such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen prep, dispersion preparation, and lyophilization. It is essential to perform these tasks meticulously to ensure the quality of our products.

Additionally, you will be responsible for the setup, operation, and cleaning of all clean room manufacturing equipment. This entails working in ISO Class 5 or ISO Class 7 areas and adhering to Clean Room gowning protocols. All operations must be conducted in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements.

Operating in a team environment, we emphasize daily achievements and maintaining high-quality standards in our production processes. Encourage teamwork and open communication as we work towards our daily goals. Your dedication is crucial to our collective success. Additionally, engage in administrative activities such as training, investigations, and inventory management within our manufacturing area.

Monday to Thursday role, shift is 6am to 4:30pm

ESSENTIAL DUTIES AND RESPONSIBILITIES

People

• Allocate resources to meet daily schedule needs and support plan development and execution
• Partner with area management to identify overtime needs in advance
• Communicate with support groups on daily processing needs
• Provide feedback to department management on operator and process performance
• Interface with support departments to establish clear/consistent manufacturing objectives and needs

Process

• Perform all requirements of a Manufacturing Operator
• Provide daily oversight of the medical manufacturing operations
• Actively engage in all areas of the manufacturing process
• Identify and resolve training gaps (process, performance, paperwork) through the execution of a training plan.
• Own operator training for all new Chemical Operators
• Lead troubleshooting initiatives to minimize equipment/process downtime
• Identify equipment deficiencies and observe operator performance in manufacturing
• Support investigations as a subject matter expert
• Maintain process and component inventories
• Support time management around start/stop, breaks and timely completion of tasks

Paperwork

• Obtain batch records in advance for associated manufacturing operations to prevent delays
• Document manufacturing activities in real time and perform daily in-process checks of paperwork
• Supply and receive paperwork from support groups when necessary to maintain manufacturing operations on a consistent and progressive basis
• Provide comments in batch records not limited to non-conformance references or other clarifications
• Perform daily, in-process reviews of batch records to support good documentation practices
• Develop, redline, and/or review associated manufacturing documentation

DESIRED MINIMUM QUALIFICATIONS

• High School diploma or equivalent. Degree related to science.
• 3-5 years of chemical processing experience or batch mixing in manufacturing environment in the Medical Device or Pharmaceutical industry preferred.
• 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
• Understand product flow and understand chemical process and its impact
• Able to work overtime

TOOLS AND EQUIPMENT USED

Lyophilizers, homogenizers, Tornado Mill, vacuum pump, pH meters, thermometers, balances (scales), water bath circulators, humidity cabinet, centrifuge, blenders, air gun, Filamatic filling machines, drop indicator, scalpels, pouch sealers and Honeywell temperature recorders

PHYSICAL REQUIREMENTS

• 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.
• 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.

The physical requirements listed in this section include, but are