Aseptic Production Operator II — Pharma Impact & Quality

Indivior in; Raleigh (NC); On-site; USD 34,000 - 45,000; Full time

Benefits offered by this job

Competitive PTO

Bonus program

Long-Term Incentive Plan

401(k) and Profit Sharing

Employee Stock Purchase Plan

Medical/Dental/Vision/Life/Disability

Tuition reimbursement

Adoption assistance

Wellness programs

Other perks

Job summary

Indivior is seeking an Operator II, Aseptic Production to operate and monitor aseptic manufacturing equipment and processes. The role emphasizes strict adherence to cGMP, thorough data review, and meticulous documentation of batch records to ensure high-quality parenteral products.

The position requires a minimum of three years in a regulated environment, gowning in classified areas, and strong attention to detail. Competitive benefits and salary are highlighted in the program.

Qualifications

• Minimum three (3) years' experience in a regulated environment.
• Gowning experience in a classified area is required.
• Understanding of Aseptic techniques required.
• Knowledge of cGMPs.
• Ability to read, understand, interpret, and apply technical writing and instructions.

Responsibilities

• Operate and monitor aseptic processing equipment (steam sterilizers, filling, capping, lyophilizer) and associated equipment.
• Ensure equipment cleanliness and proper setup for product runs.
• Review raw cycle data to ensure process standards and compliance.
• Document production activities and batch records accurately.
• Maintain a safe work environment and report hazardous conditions or incidents.
• Deliver, handle, receive and store bulk and finished drug products per SOPs.

Skills

Aseptic techniques

cGMP knowledge

Attention to detail

Good communication

Basic math/science

Batch records handling

Mechanical aptitude

Computer literacy

Education

High School Diploma

Tools

Batch record software

Job description

Indivior is seeking an Operator II, Aseptic Production to operate and monitor aseptic manufacturing equipment and processes. The role emphasizes strict adherence to cGMP, thorough data review, and meticulous documentation of batch records to ensure high-quality parenteral products.

The position requires a minimum of three years in a regulated environment, gowning in classified areas, and strong attention to detail. Competitive benefits and salary are highlighted in the program.