Aseptic Production Operator II — Parenteral Manufacturing

Indivior PLC; Raleigh (NC); On-site; USD 28,000 - 34,000; Full time

Benefits offered by this job

Starting salary / bonus eligible

Job summary

Indivior is seeking an Aseptic Production Operator II to operate processing and test equipment in aseptic areas, applying rigorous cGMP practices to produce parenteral products.

You will support manufacturing, maintain cleanlines, review batch data, and work with QA and maintenance to ensure quality and compliance. This role requires a high school diploma, 1 year regulated environment experience, gowning in classified areas, and strong attention to detail.

Qualifications

• High School Diploma required.
• Minimum one year of experience in a regulated environment.
• Gowning in a classified area required.
• Knowledge of cGMPs.
• Basic math and science skills and the ability to use a computer.
• Demonstrated ability to read, understand, interpret, and apply technical writing and instruction.
• Strong communication skills: both verbal and written.
• Attention to detail.
• Experience with batch records handling, and a broad understanding of pharmaceutical production.
• Mechanical aptitude preferred.

Responsibilities

• Complies with cGMP through adherence to SOP’s, Master Batch Record Instructions, and company policies with a focus on quality and safety to produce parenteral products that improve public health.
• Ensure training maintains compliance with the job role before performing any activities in the production operation.
• Ensures that the equipment is cleaned and maintained properly, and the work areas are clean and maintained as required.
• Responsible for reviewing raw cycle data to ensure process standards are met.
• Exercises sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product.
• Communicates with Production management, Quality Assurance, Quality Control, Maintenance and Engineering staff pertaining to status of manufacturing operations.
• Monitors manufacturing cycles.
• Verify and document production activities both manually and on computer systems to ensure requirements of production have been met.
• Responsible for maintaining a safe work environment and reporting any potentially hazardous conditions or safety incidents.
• Cleaning, Setup, and adjustments of equipment as required for proper operation.
• Operate a variety of production equipment to support production operations.
• Receive, check, store, handle and deliver bulk and finished drug products as required.
• Utilize appropriate material handling equipment in accordance with standard operating safety policies.

Skills

Attention to detail

Strong communication

Gowning experience

cGMP knowledge

Mechanical aptitude

Math & science basics

Reading technical writing

Computer literacy

Batch records experience

Education

High School Diploma

Job description

Indivior is seeking an Aseptic Production Operator II to operate processing and test equipment in aseptic areas, applying rigorous cGMP practices to produce parenteral products.

You will support manufacturing, maintain cleanlines, review batch data, and work with QA and maintenance to ensure quality and compliance. This role requires a high school diploma, 1 year regulated environment experience, gowning in classified areas, and strong attention to detail.