Manufacturing Operator 1

Integra LifeSciences Corporation; Plainsboro Township (NJ); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Clean Room Manufacturing Operator to join their dynamic team. This role is vital for ensuring the quality of healthcare products through precise operations in a cleanroom environment. You will be responsible for handling collagen materials, operating specialized equipment, and maintaining compliance with strict regulatory standards. The position offers the opportunity to work in a collaborative atmosphere where your contributions will directly impact patient outcomes. If you are detail-oriented and passionate about healthcare innovation, this is the perfect opportunity for you.

Qualifications

• Ability to perform essential duties with a focus on safety and teamwork.
• Experience in cleanroom operations and compliance with regulatory standards.

Responsibilities

• Operate and maintain clean room manufacturing equipment.
• Ensure compliance with GMP and ISO standards.
• Record production activities accurately.

Skills

GMP Compliance

ISO Standards Knowledge

Chemical Handling

Equipment Operation

Record Keeping

Education

High School Diploma

Technical Certification

Tools

Oracle MRP Systems

Lyophilization Equipment

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.

Role Overview: Clean Room Manufacturing Operator

This Clean Room Manufacturing Operator role involves processes such as enzymatic treatment of collagen, alkali treatment of collagen, tendon collagen preparation, dispersion preparation, and lyophilization. Precise execution of these tasks is essential to ensure product quality.

You will also be responsible for setting up, operating, and cleaning all clean room manufacturing equipment, working in ISO Class 5 or ISO Class 7 areas, and adhering to gowning protocols. All activities must comply with GMP, Quality Systems Regulations, SOPs, and Health and Safety standards.

Key Responsibilities

1. Operate, maintain, and troubleshoot process equipment, making minor adjustments as needed.
2. Perform precise measurements, accurately adding chemicals to batches.
3. Handle blending, mixing, pouring, and loading collagen materials into lyophilizing equipment.
4. Pass and maintain gowning qualifications for ISO Class 5 or 7 cleanroom operations.
5. Maintain accurate records, logs, and documentation to comply with regulatory standards.
6. Coordinate with QA/QC and Material departments for inspections and workflow.
7. Record production activities in Oracle MRP systems.
8. Follow SOPs, GMP, and ISO 13485 requirements.
9. Handle decontamination and cleaning of supplies, instruments, and equipment.
10. Report discrepancies to supervisors.
11. Support safety initiatives and maintain a clean, organized workspace.
12. Work flexible shifts and perform other assigned manufacturing activities.

Qualifications and Requirements

Applicants should be capable of performing each essential duty satisfactorily, with a focus on safety, accuracy, and teamwork.

Equal Opportunity Statement

Integra LifeSciences is an equal opportunity employer committed to diversity and inclusion. We provide accommodations for applicants with disabilities. For assistance, contact [e-mail] or call 855-936-2666.