Operator I, Aseptic Production

Indivior • Raleigh, NC

4d • Onsite

About The Position

The Aseptic Production Operator I position is responsible for the operation of various types of processing and test equipment in aseptic areas, using excellent aseptic practices and behaviors, per Standard Operating Procedures. This includes but is not limited to steam sterilizers, filling equipment, performing interventions, capping equipment, Lyophilizer and other associated equipment. As part of these responsibilities, the Aseptic Production Operator I monitors operations, completes and/or reviews data to ensure requirements have been met and completes all associated documentation. The Aseptic Production Operator levels are differentiated based on the ability to perform tasks in various areas independently and with a high level of proficiency and knowledge of the area and equipment. Operator I level associates will be expected to meet these minimum requirements: Ability to receive training, understand what is taught and execute as instructed. Signed off on at least 25% of the OJT requirements for your area of focus within 6 months. Understand the Indivior Values & Behaviors.

Requirements

• High School Diploma required
• Minimum one (1) year experience in a regulated environment required
• Gowning experience in a classified area is required.
• Knowledge of cGMPs.
• Basic math and science skills and the ability to use a computer.
• Demonstrated ability to read, understand, interpret, and apply technical writing and instruction.
• Strong communication skills: both verbal and written.
• Attention to detail.
• Experience with batch records handling, and a broad understanding of pharmaceutical production.

Nice To Haves

• Mechanical aptitude preferred.

Responsibilities

• Complies with cGMP through adherence to SOP’s, Master Batch Record Instructions, and company policies with a focus on quality and safety to produce parenteral products that improve the public health.
• Ensure training maintains compliance with the job role before performing any activities in the production operation.
• Ensures that the equipment is cleaned and maintained properly, and the work areas are clean and maintained as required. This requires sanitization of walls, ceilings and floors as well as counter tops and tables.
• Clear and clean production lines as required before and after all operations.
• Responsible for reviewing raw cycle data to ensure process standards are met. Analytical reasoning ability and an understanding of the principles of cGMP production are required to accurately assess compliance to cycle standards.
• Exercises sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product.
• Communicates with Production management, Quality Assurance, Quality Control, Maintenance and Engineering staff pertaining to status of manufacturing operations, including but not limited to equipment reliability, environmental problems, and potential quality & compliance concerns.
• Monitors manufacturing cycles.
• Verify and document production activities both manually and on computer systems, including batch records, logbooks, etc. to ensure requirements of production have been met.
• Responsible for maintaining a safe work environment and reporting any potentially hazardous conditions or safety incidents immediately to your supervisor.
• Cleaning, Setup, and adjustments of equipment as required for proper operation, including disassembly and installation of all equipment and parts required for product runs.
• Operate a variety of production equipment, as mentioned above, to support production operations.
• Receive, check, store, handle and deliver bulk and finished drug products as required or directed.
• Utilize appropriate material handling equipment in accordance with standard operating safety policies.
• Follow established SOPs and documentation procedures
• Perform additional duties and responsibilities as assigned

Benefits

• Competitive PTO plus company closure from December 24th- January 1st
• Eligible to participate in Indivior’s bonus program, based on company and individual performance
• Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan
• 401(k) and Profit-Sharing Plan- Company match
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Wellness programs as well as other discounts and perks

What This Job Offers

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