Aseptic Production Technician II

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

Benefits offered by this job

Bonus program

LTIP grant

PTO + company closure

401(k) match

Employee stock purchase plan

Comprehensive medical, dental, vision

Wellness programs

Job summary

Indivior is seeking an Aseptic Production Operator II to operate and monitor parenteral production equipment in aseptic areas, adhering to cGMP and SOPs. You will handle steam sterilizers, filling, capping, lyophilization, and related operations while ensuring data integrity in batch records.

The role requires at least 1 year in a regulated environment, gowning in classified areas, and strong math/science skills with good communication.

Qualifications

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

Responsibilities

• Complies with cGMP through SOPs, Master Batch Records, and policies to produce parenteral products.
• Ensure training remains compliant with the job role before tasks.
• Maintain cleaning and proper condition of equipment and work areas.
• Review raw cycle data to verify process standards and compliance.
• Communicate with Production management, QA, QC, and Maintenance staff about operations.
• Monitor manufacturing cycles and document activities in batch records and logs.
• Maintain a safe work environment and report hazards or incidents immediately.
• Set up, adjust, and operate equipment required for product runs; assist with disassembly if needed.
• Receive, check, store, handle and deliver bulk and finished drug products per directions.

Skills

Attention to detail

Communication skills

Mechanical aptitude

Education

High School Diploma

Job description

Indivior is seeking an Aseptic Production Operator II to operate and monitor parenteral production equipment in aseptic areas, adhering to cGMP and SOPs. You will handle steam sterilizers, filling, capping, lyophilization, and related operations while ensuring data integrity in batch records.

The role requires at least 1 year in a regulated environment, gowning in classified areas, and strong math/science skills with good communication.