Aseptic Production Operator II – Parenteral Meds Expert

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

Benefits offered by this job

Competitive PTO

Yearly bonus program

Long-Term Incentive Plan

401(k) match

Employee Stock Purchase Plan

Medical, dental, vision

Health Savings Account options

Adoption assistance

Tuition reimbursement

Wellness programs

Job summary

Indivior is seeking an Operator II, Aseptic Production to operate sterilization and filling equipment in aseptic areas, maintaining strict aseptic practices and documentation.

You'll monitor processes, review data, and ensure quality and safety standards are met, with responsibilities spanning equipment setup, cleaning, and material handling for bulk and finished drug products. Prior GMP experience preferred.

Qualifications

• High School Diploma required.
• Minimum three years in a regulated environment.
• Gowning experience in a classified area required.
• Understanding of aseptic techniques required.
• Knowledge of cGMPs.
• Basic math and science skills; ability to use a computer.
• Strong reading, understanding, interpretation of technical writing and instruction.
• Strong verbal and written communication skills.
• Attention to detail.
• Experience with batch records handling and pharmaceutical production.

Responsibilities

• Complies with cGMP and SOPs to produce parenteral products.
• Ensure training maintains compliance before activities.
• Maintain and clean equipment and work areas.
• Review raw cycle data to ensure process standards.
• Exercise sound judgment and attention to detail to protect equipment/product.
• Communicate with Production management, QA, QC, Maintenance and Engineering about operations.
• Monitor manufacturing cycles and document activities in batch records and logbooks.
• Maintain a safe work environment and report hazards.
• Set up and adjust equipment for proper operation; operate production equipment.
• Receive, check, store, handle and deliver bulk and finished drug products; use material handling equipment.

Skills

Aseptic techniques

cGMP knowledge

Batch records handling

Analytical thinking

Attention to detail

Basic math and science

Communication skills

Mechanical aptitude

Education

High School Diploma

Job description

Indivior is seeking an Operator II, Aseptic Production to operate sterilization and filling equipment in aseptic areas, maintaining strict aseptic practices and documentation.

You'll monitor processes, review data, and ensure quality and safety standards are met, with responsibilities spanning equipment setup, cleaning, and material handling for bulk and finished drug products. Prior GMP experience preferred.