Environmental Monitoring Technician

Title

Environmental Monitoring Technician

Title: Environmental Monitoring Technician

Reports To: Environmental Monitoring Supervisor

Location: Raleigh, NC

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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

Position Summary

The purpose of the EM Technician I is to perform routine environmental monitoring to assess the viable and nonviable particulate levels within classified manufacturing rooms and support rooms.

Essential Functions

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

• Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas (Compounding, Component Preparation, Vial Wash, and Dispensary)
• Collect facility waters and submit for testing and accurately record results of above testing and promptly report any discrepancies or out of limit conditions to supervisor
• Perform Aseptic Gowning Training and certification sampling
• Requisition of materials, maintaining inventory and receive and store prepared media
• Prepare environmental monitoring plates and EM test reports for aseptic processing area
• Perform disinfection of incubator rooms weekly
• Follow safety requirements and maintains good housekeeping of laboratory area
• Incubate and inspect media fill units and incubate and examine samples for microbial growth
• Enumerate bacteria and report excursions
• Temperature charts for incubators and refrigerators in the Microbiology Laboratory
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
• Assume additional duties and responsibilities as assigned
  
  

Minimum Qualifications

• Bachelor’s degree in Chemistry, Microbiology, Biology or other related Science from an accredited university
• May consider an Associate’s degree from an accredited university with minimum 3 (three) years of experience in the pharmaceutical industry (cGMP environment) and aseptic technique
• May consider a High School Diploma with minimum 5 (five) years of experience in the pharmaceutical industry (cGMP environment) and aseptic technique
• Minimum 1 (one) year’s experience in the pharmaceutical industry (cGMP environment) and aseptic technique
• Ability to get gowning certified within 30 days
• Physical Requirements include - standing and walking up to 8 hours (4 hours at a time for aseptic processing area), lifting or moving up to 35 pounds and reaching with hands and arms up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl up to 1 hour.
• Must be flexible for working across shifts (nights and/or weekends) as needed
  
  

Competencies/Conduct

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

• A ‘See it, Own it, Make it Happen’ attitude.
• Excellent problem solving and critical thinking skills.
• Strong attention to detail and ability to follow standard procedures.
• Team collaboration and professional behaviors to align with Indivior guiding principles and core values.
• Good interpersonal and communication skills
  
  

Benefits

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:

• 3 weeks’ vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
• 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
• Gym, fitness facility and cell phone discounts
  
  

Guiding Principles

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

Compliance Obligations

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 behaviour. As part of your responsibilities, you are expected to:

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.
  
  

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.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled