Operator II, Aseptic Production

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

Benefits offered by this job

Competitive PTO

Bonus program

Long-Term Incentive Plan

401(k) and Profit Sharing

Employee Stock Purchase Plan

Medical/Dental/Vision/Life/Disability

Tuition reimbursement

Adoption assistance

Wellness programs

Other perks

Job summary

Indivior is seeking an Operator II, Aseptic Production to operate and monitor aseptic manufacturing equipment and processes. The role emphasizes strict adherence to cGMP, thorough data review, and meticulous documentation of batch records to ensure high-quality parenteral products.

The position requires a minimum of three years in a regulated environment, gowning in classified areas, and strong attention to detail. Competitive benefits and salary are highlighted in the program.

Qualifications

• Minimum three (3) years' experience in a regulated environment.
• Gowning experience in a classified area is required.
• Understanding of Aseptic techniques required.
• Knowledge of cGMPs.
• Ability to read, understand, interpret, and apply technical writing and instructions.

Responsibilities

• Operate and monitor aseptic processing equipment (steam sterilizers, filling, capping, lyophilizer) and associated equipment.
• Ensure equipment cleanliness and proper setup for product runs.
• Review raw cycle data to ensure process standards and compliance.
• Document production activities and batch records accurately.
• Maintain a safe work environment and report hazardous conditions or incidents.
• Deliver, handle, receive and store bulk and finished drug products per SOPs.

Skills

Aseptic techniques

cGMP knowledge

Attention to detail

Good communication

Basic math/science

Batch records handling

Mechanical aptitude

Computer literacy

Education

High School Diploma

Tools

Batch record software

Job description

Operator II, Aseptic Production (Finance)

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

Position Overview

The Aseptic Production Operator II 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 II monitors operations, completes and/or reviews data to ensure requirements have been met and completes all associated documentation.

How you'll make an impact

• 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.

What you'll bring

• High School Diploma required
• Minimum three (3) years' experience in a regulated environment required.
• Gowning experience in a classified area is required.
• Understanding of Aseptic techniques 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.
• Mechanical aptitude preferred.

In addition to the minimum qualifications, the employee will demonstrate:

• Embrace Indivior core culture principles
• Embrace the dynamics of team support, team collaboration and team success
• Celebrate the core wins of the organization and empower others to sustain a quality mindset
• Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives
• Celebrate and embrace diversity, equity, and inclusion

How we invest in our people

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

Starting Salary: $25.00-$33.00 an hour

*Note actual salary is based on qualifications and experience

• 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

Our shared responsibility for ethical conduct

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior.

Employee Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled are encouraged to apply!

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

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