Manufacturing Operator II

Integra LifeSciences; Plainsboro Township (NJ); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading healthcare company is seeking a Manufacturing Operator II to perform critical post-formulation processing in a clean room environment. This role involves operating equipment, maintaining compliance with safety standards, and collaborating with team members to meet production goals. Candidates should possess a high school diploma and have basic skills in mathematics and chemistry. The position requires teamwork and the ability to work flexible shifts.

Qualifications

• 0-2 years of chemical processing or batch mixing experience in a clean room environment.
• Ability to operate, troubleshoot, and adjust process equipment.

Responsibilities

• Perform post-formulation processing including product cutting and packaging.
• Maintain accurate records and comply with regulatory requirements.
• Operate and troubleshoot process equipment used in collagen production.

Skills

Teamwork

Basic Mathematics

Basic Chemistry

Computer Skills

English Proficiency

Education

High School Diploma

Related Science Degree

Tools

Lyophilizers

Autoclaves

Homogenizers

Grinders

pH Meters

Job description

Join to apply for the Manufacturing Operator II role at Integra LifeSciences

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.

This Manufacturing Operator II - 1st Shift will perform 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 like cross-linking required to produce collagen-based products. All work streams include 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 in compliance with GMP, Quality Systems Regulations, SOPs, and Health and Safety standards. Operate in a team environment focused on daily milestones and quality.

This is a 1st Shift position, working from 7:00 a.m. to 3:00 p.m.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Operate, maintain, and troubleshoot process equipment used in collagen production, making minor adjustments as needed.
• Perform precise measurements and use measurement equipment to accurately add chemicals to batches.
• Blend, mix, pour, and load collagen material into lyophilizing equipment.
• Pass and maintain gowning qualification for ISO Class 5 and 7 Clean room operations.
• Maintain accurate records, logs, and documentation to comply with regulatory requirements, GMP, SOPs, and safety standards.
• Coordinate with QA/QC/Material departments for inspections and efficient workflow.
• Record production activities in Oracle MRP systems, including material and labor tracking.
• Follow SOPs, GMP, and ISO 13485 standards.
• Handle, decontaminate, and clean production supplies and equipment.
• Report discrepancies to supervisors or group leaders.
• Support safety goals by demonstrating safe behaviors.
• Maintain a clean and organized work area.
• Work flexible shifts and days to meet batch milestones.
• Perform other activities as assigned.

Minimum Qualifications

• High School diploma or equivalent; related science degree is a plus.
• 0-2 years of chemical processing or batch mixing experience, preferably in a medical device or pharmaceutical clean room environment.
• Basic computer skills for email and data entry.
• Proficiency in English (reading, writing, speaking).
• Understanding of basic mathematics and chemistry.
• Ability to work in a team and independently.
• Ability to operate, troubleshoot, and adjust process equipment.
• Gowning qualification for ISO Class 5 and 7 clean rooms.
• Ability to work overtime as needed.

Tools and Equipment Used

• Lyophilizers, autoclaves, homogenizers, grinders, vacuum pumps, pH meters, thermometers, scales, water baths, sonicators, humidity cabinets, mixers, centrifuges, blenders, air guns, drop indicators, filling machines, slicers, scalpels, temperature recorders, crosslinking chambers, humidification chambers, compression units, cutting tables, sealing and shrink wrap machines.

Physical Requirements

• Ability to sit, listen, speak, write, and type repeatedly.
• Stand for up to 8 hours, lift up to 60 lbs, and climb ladders.
• Work in all company areas, including gowning in ISO Class 5 and 7 clean rooms.
• Vision must be correctable to 20/25, with normal color perception.

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