Operator III, Aseptic Production

Indivior PLC; Raleigh (NC); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Bonus program

401(k) and Profit-Sharing Plan

Employee Stock Purchase Plan - 15% DIS

Comprehensive Medical, Dental, Vision,

Life and Disability coverage

Tuition reimbursement

Wellness programs

Job summary

Indivior PLC is seeking an Aseptic Production Operator I in Raleigh, NC. The role entails operating aseptic processing and test equipment, maintaining sanitation and data records, and ensuring compliance with cGMP and SOPs.

The candidate should have at least five years in a regulated environment and gowning in classified areas. The position emphasizes meticulous data review, strong communication with cross-functional teams, and safe operation of production lines to deliver parenteral products.

Qualifications

• High School Diploma required.
• Minimum five (5) years’ experience in a regulated environment.
• Gowning experience in a classified area is required.
• Understanding of Aseptic techniques required.
• Knowledge of cGMPs.
• Basic math and science skills and ability to use a computer.
• Read, understand, interpret, and apply 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, SOPs, and MBIs to produce parenteral products.
• Ensure training remains compliant before performing production activities.
• Maintain clean and sanitized work areas and equipment.
• Review raw cycle data to verify process standards.
• Communicate with Production, QA, QC, Maintenance and Engineering staff regarding status and issues.
• Monitor manufacturing cycles and document activities in batch records and logbooks.

Skills

Aseptic techniques

cGMP knowledge

Attention to detail

Strong communication

Mechanical aptitude

Reading technical writing

Analytical reasoning

Batch records handling

Data entry/computer use

Education

High School Diploma

Job description

TITLE:Operator III, Aseptic ProductionWHO WE AREIndivior 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 OVERVIEWThe 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.HOW YOU’LL MAKE AN IMPACTThe 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.WHAT YOU’LL BRINGHigh School Diploma requiredMinimum five (5) 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.HOW WE INVEST IN OUR PEOPLEIndivior 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: $30.00-$40.00 per hour*Note actual salary is based on qualifications and experienceCompetitive PTO plus company closure from December 24th- January 1stEligible to participate in Indivior’s bonus program, based on company and individual performanceEligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan401(k) and Profit-Sharing Plan- Company matchU.S. Employee Stock Purchase Plan- 15% DiscountComprehensive Medical, Dental, Vision, Life and Disability coverageHealth, Dependent Care and Limited Purpose Flex Spending and HSA optionsAdoption assistanceTuition reimbursementConcierge/personal assistance servicesVoluntary benefits including Legal, Pet Insurance and Critical Illness coverageWellness programs as well as other discounts and perksOUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCTIndivior 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 pressureRisk 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 pressureReinforce 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 OPPORTUNITYEOE/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 www.indivior.com or follow us at www.linkedin.com/company/Indivior.#LI-AC1