Operator II, Aseptic Production

Indivior Manufacturing LLC (Hourly); Raleigh (NC); On-site; USD 28,000 - 34,000; Full time

Benefits offered by this job

Starting salary / bonus eligible

Job summary

Indivior is seeking an Aseptic Production Operator II to operate processing and test equipment in aseptic areas, applying rigorous cGMP practices to produce parenteral products.

You will support manufacturing, maintain cleanlines, review batch data, and work with QA and maintenance to ensure quality and compliance. This role requires a high school diploma, 1 year regulated environment experience, gowning in classified areas, and strong attention to detail.

Qualifications

• High School Diploma required.
• Minimum one year of experience in a regulated environment.
• Gowning in a classified area 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.

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 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.
• Responsible for reviewing raw cycle data to ensure process standards are met.
• 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.
• Monitors manufacturing cycles.
• Verify and document production activities both manually and on computer systems to ensure requirements of production have been met.
• Responsible for maintaining a safe work environment and reporting any potentially hazardous conditions or safety incidents.
• Cleaning, Setup, and adjustments of equipment as required for proper operation.
• Operate a variety of production equipment to support production operations.
• Receive, check, store, handle and deliver bulk and finished drug products as required.
• Utilize appropriate material handling equipment in accordance with standard operating safety policies.

Skills

Attention to detail

Strong communication

Gowning experience

cGMP knowledge

Mechanical aptitude

Math & science basics

Reading technical writing

Computer literacy

Batch records experience

Education

High School Diploma

Job description

WHO WE ARE

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. 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.

HOW YOU’LL MAKE AN IMPACT

The responsibilities of this job include, but are not limited to, the following:

• 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.

General Duties

Follow established SOPs and documentation procedures

Perform additional duties and responsibilities as assigned

WHAT YOU’LL BRING

• 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.
• Mechanical aptitude preferred.

PHYSICAL REQUIREMENTS

Position requires continuous standing and walking. Frequent bending over and lifting and carrying up to 50 lbs. Must wear appropriate PPE as required. Good Vision

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

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.

Indivior experience includes:

• Starting Salary: $20.00-$25.00 per hour *Note actual salary is based on qualifications and experience
• 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
• Competitive PTO plus company closure from December 24th- January 1st
• 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.

Indivior Guiding Principles

• Focus on Patient Needs to Drive Decisions
• Believe that People’s Actions are Well Intended
• Seek the Wisdom of the Team
• Care Enough to Coach
• See it, Own it, Make it Happen
• Demonstrate Honesty and Integrity at All Times

Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.

#LI-AC1 Passion. Innovation. Achievement. All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient.

Indivior leadership team has built a global organization of individuals connected by a thriving culture. Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. It is our set of “Guiding Principles” that we believe have nurtured our culture and successfully guided our decision making.

For those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you.