Operator II, Aseptic Production

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

Benefits offered by this job

Competitive PTO

Yearly bonus program

Long-Term Incentive Plan

401(k) match

Employee Stock Purchase Plan

Medical, dental, vision

Health Savings Account options

Adoption assistance

Tuition reimbursement

Wellness programs

Job summary

Indivior is seeking an Operator II, Aseptic Production to operate sterilization and filling equipment in aseptic areas, maintaining strict aseptic practices and documentation.

You'll monitor processes, review data, and ensure quality and safety standards are met, with responsibilities spanning equipment setup, cleaning, and material handling for bulk and finished drug products. Prior GMP experience preferred.

Qualifications

• High School Diploma required.
• Minimum three years in a regulated environment.
• Gowning experience in a classified area required.
• Understanding of aseptic techniques required.
• Knowledge of cGMPs.
• Basic math and science skills; ability to use a computer.
• Strong reading, understanding, interpretation of technical writing and instruction.
• Strong verbal and written communication skills.
• Attention to detail.
• Experience with batch records handling and pharmaceutical production.

Responsibilities

• Complies with cGMP and SOPs to produce parenteral products.
• Ensure training maintains compliance before activities.
• Maintain and clean equipment and work areas.
• Review raw cycle data to ensure process standards.
• Exercise sound judgment and attention to detail to protect equipment/product.
• Communicate with Production management, QA, QC, Maintenance and Engineering about operations.
• Monitor manufacturing cycles and document activities in batch records and logbooks.
• Maintain a safe work environment and report hazards.
• Set up and adjust equipment for proper operation; operate production equipment.
• Receive, check, store, handle and deliver bulk and finished drug products; use material handling equipment.

Skills

Aseptic techniques

cGMP knowledge

Batch records handling

Analytical thinking

Attention to detail

Basic math and science

Communication skills

Mechanical aptitude

Education

High School Diploma

Job description

TITLE:

Operator II, Aseptic Production

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.

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:

Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company. The following benefits are provided by Indivior, subject to eligibility requirements.

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.

Want to learn more? Connect with us at