Operator II, Aseptic Production

Indivior•Raleigh, NC

About The Position

The Aseptic Production Operator II operates processing and testing equipment in aseptic areas, following Standard Operating Procedures and applying excellent aseptic practices. Equipment may include steam sterilizers, filling and capping equipment, lyophilizers, and associated equipment. The role monitors manufacturing operations and cycles, reviews raw cycle data, and completes or reviews records to verify that process and production requirements have been met. Operator levels are differentiated by the ability to perform tasks independently and with proficiency and knowledge of the relevant area and equipment. The position supports compliant production of parenteral products by following cGMP requirements, maintaining clean equipment and work areas, preparing and adjusting equipment, handling materials, and communicating operational, equipment, environmental, quality, and compliance concerns to relevant teams. The role requires attention to detail, sound judgment, and adherence to safety and documentation procedures. The position requires continuous standing and walking, frequent bending, and lifting and carrying up to 50 pounds. Appropriate PPE must be worn as required. Employees must report health conditions that could adversely affect drug-product safety or quality; personnel with certain illnesses or open lesions may be excluded from direct product contact until the condition is corrected or assessed by competent medical personnel.

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 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.
Ability to stand and walk continuously, bend frequently, and lift and carry up to 50 pounds.
Wear appropriate PPE as required.
Good vision.

Nice To Haves

Mechanical aptitude.

Responsibilities

Follow cGMP requirements, SOPs, Master Batch Record instructions, and company policies to support safe, quality production of parenteral products.
Maintain required training compliance before performing production activities.
Clean and maintain equipment and work areas, including sanitizing walls, ceilings, floors, countertops, and tables as required.
Clear and clean production lines before and after operations as required.
Review raw cycle data and assess whether process standards have been met.
Use sound judgment and attention to detail to recognize and avert situations that could adversely affect equipment or product.
Communicate the status of manufacturing operations and concerns involving equipment reliability, environmental problems, quality, or compliance to Production management, Quality Assurance, Quality Control, Maintenance, and Engineering staff.
Monitor manufacturing cycles.
Verify and document production activities manually and in computer systems, including batch records and logbooks.
Maintain a safe work environment and promptly report hazardous conditions or safety incidents to a supervisor.
Clean, set up, and adjust equipment, including disassembling and installing equipment and parts required for product runs.
Operate production equipment to support manufacturing operations.
Receive, check, store, handle, and deliver bulk and finished drug products as required or directed.
Use appropriate material-handling equipment in accordance with 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 for a yearly grant as part of 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 account 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.