Operator II, Aseptic Production

Indivior • Raleigh, NC

3d • $20 - $25

About The Position

The Aseptic Production Operator II operates processing and test equipment in aseptic areas, following Standard Operating Procedures and applying strong aseptic practices. Equipment includes steam sterilizers, filling and capping equipment, lyophilizers, and related machinery. The role monitors manufacturing operations and cycles, reviews data to confirm process standards are met, and completes associated documentation. Operator levels are differentiated by the ability to perform tasks in assigned areas independently and with proficiency and knowledge of the area and equipment.

The position supports the production of parenteral products in a regulated environment. It involves equipment setup, cleaning, adjustments, and maintenance; production-line clearance; material handling; documentation; and communication with production, quality, maintenance, and engineering teams. Employees must follow cGMP requirements, maintain safety and product quality, and report hazardous conditions or potential compliance concerns.

Requirements

• High school diploma.
• At least one year of experience in a regulated environment.
• Gowning experience in a classified area.
• Knowledge of cGMPs.
• Basic math and science skills and the 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.
• Continuous standing and walking.
• Frequent bending and lifting or carrying up to 50 pounds.
• Ability to wear appropriate personal protective equipment as required.
• Good vision.
• Report health conditions that may adversely affect drug products to supervisory personnel; personnel with certain illnesses or open lesions may be excluded from direct contact with product-related materials until the condition is corrected or determined not to jeopardize product safety or quality.

Nice To Haves

• Mechanical aptitude.
• Experience handling batch records and a broad understanding of pharmaceutical production.

Responsibilities

• Follow cGMP requirements, SOPs, Master Batch Record Instructions, and company policies, with a focus on quality and safety.
• Maintain required training compliance before performing production activities.
• Clean and maintain equipment and work areas, including sanitizing walls, ceilings, floors, countertops, and tables, and clearing production lines before and after operations.
• Review raw cycle data and use analytical reasoning and knowledge of cGMP production to verify process standards are met.
• Use sound judgment and attention to detail to recognize and avert situations that could adversely affect equipment or product.
• Communicate manufacturing status, 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.
• Clean, set up, adjust, disassemble, and install equipment and parts as needed for proper operation and product runs.
• Operate production equipment, including steam sterilizers, filling equipment, capping equipment, and lyophilizers.
• Receive, check, store, handle, and deliver bulk and finished drug products as required, using material-handling equipment according to safety policies.
• Follow established SOPs and documentation procedures.
• Perform additional duties and responsibilities as assigned.

Benefits

• Eligible to participate in a bonus program based on company and individual performance.
• Eligible to receive a yearly grant through the Long-Term Incentive Plan.
• Competitive paid time off and company closure from December 24 through January 1.
• 401(k) and profit-sharing plan with company match.
• U.S. Employee Stock Purchase Plan with a 15% discount.
• Medical, dental, vision, life, and disability coverage.
• Health, dependent care, and limited-purpose flexible spending accounts and HSA options.
• Adoption assistance.
• Tuition reimbursement.
• Concierge and personal assistance services.
• Voluntary benefits, including legal, pet insurance, and critical illness coverage.
• Wellness programs, discounts, and other perks.

What This Job Offers

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