Operator III, Aseptic Production

Indivior • Raleigh, NC

1d • $30 - $40

About The Position

The Aseptic Production Operator operates processing and test equipment in aseptic areas, using excellent aseptic practices and following Standard Operating Procedures. Equipment includes steam sterilizers, filling and capping equipment, lyophilizers, and associated equipment. The operator monitors manufacturing operations and cycles, reviews raw cycle data, verifies and documents production activities, and completes or reviews data to ensure process and production requirements are met. The role also involves cleaning and maintaining equipment and work areas, complying with cGMP and safety requirements, and communicating manufacturing status and potential quality or compliance concerns to relevant teams.

Requirements

• High school diploma.
• At least five years of experience in a regulated environment.
• Gowning experience in a classified area.
• Understanding of aseptic techniques.
• Knowledge of cGMPs.
• Basic math and science skills and ability to use a computer.
• Ability to read, understand, interpret, and apply technical writing and instructions.
• Strong verbal and written communication skills.
• Attention to detail.
• Experience handling batch records and a broad understanding of pharmaceutical production.

Nice To Haves

• Mechanical aptitude.

Responsibilities

• Follow cGMP requirements, SOPs, Master Batch Record Instructions, and company policies, with a focus on quality and safety.
• Maintain required training and compliance before performing production activities.
• Clean and maintain equipment and work areas, including sanitizing walls, ceilings, floors, countertops, and tables, and clearing and cleaning production lines before and after operations.
• Review raw cycle data and assess whether process standards and cGMP requirements have been met.
• Use sound judgment and attention to detail to identify and avert situations that could adversely affect equipment or product.
• Communicate the status of manufacturing operations, equipment reliability, environmental problems, and potential quality or compliance concerns to Production management, Quality Assurance, Quality Control, Maintenance, and Engineering staff.
• Monitor manufacturing cycles and verify and document production activities manually and in computer systems, including batch records and logbooks.
• Maintain a safe work environment and immediately report potentially hazardous conditions or safety incidents to a supervisor.

Benefits

• Competitive paid time off and company closure from December 24 through January 1.
• Eligibility to participate in a bonus program based on company and individual performance.
• Medical, dental, vision, life, and disability coverage.
• Health, dependent care, and limited-purpose flexible spending accounts and HSA options.
• Adoption assistance.
• Tuition reimbursement.
• Concierge/personal assistance services.
• Voluntary legal, pet insurance, and critical illness benefits.
• Wellness programs, discounts, and other perks.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED