Operator II, Aseptic Production

NCBioImpact; Raleigh (NC); On-site; USD 28,000 - 34,000; Full time

Benefits offered by this job

Bonus program

LTIP grant

PTO + company closure

401(k) match

Employee stock purchase plan

Comprehensive medical, dental, vision

Wellness programs

Job summary

Indivior is seeking an Aseptic Production Operator II to operate and monitor parenteral production equipment in aseptic areas, adhering to cGMP and SOPs. You will handle steam sterilizers, filling, capping, lyophilization, and related operations while ensuring data integrity in batch records.

The role requires at least 1 year in a regulated environment, gowning in classified areas, and strong math/science skills with good communication.

Qualifications

• High School Diploma required.
• Minimum one year experience in a regulated environment required.
• Gowning experience in a classified area is required.
• Knowledge of cGMPs.
• Basic math and science skills and ability to use a computer.
• Ability to read, understand, interpret, and apply technical writing and instruction.
• Strong communication skills, both verbal and written.
• Attention to detail; batch records handling and pharmaceutical production knowledge.
• Mechanical aptitude preferred.

Responsibilities

• Complies with cGMP through SOPs, Master Batch Records, and policies to produce parenteral products.
• Ensure training remains compliant with the job role before tasks.
• Maintain cleaning and proper condition of equipment and work areas.
• Review raw cycle data to verify process standards and compliance.
• Communicate with Production management, QA, QC, and Maintenance staff about operations.
• Monitor manufacturing cycles and document activities in batch records and logs.
• Maintain a safe work environment and report hazards or incidents immediately.
• Set up, adjust, and operate equipment required for product runs; assist with disassembly if needed.
• Receive, check, store, handle and deliver bulk and finished drug products per directions.

Skills

Attention to detail

Communication skills

Mechanical aptitude

Education

High School Diploma

Job description

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.

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. 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: $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.