Engineer, Production

Title

Engineer, Production

Title: Engineer, Production

Reports To: Associate Director of Production

Location: Raleigh

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD 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.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time. Our purpose is to bring science-based, life-transforming treatments to patients. We strive to help eliminate the stigma of addiction. We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation. We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

Position Summary

The Production Engineer will be the subject matter expert (SME) for the compounding and filling equipment for prefilled syringes and responsible for all operational support and training of manufacturing personnel. The Production Engineer will plan, execute and continuously improve equipment performance, yield and competence.

Essential Functions

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

• Lead cross functional teams to solve urgent production issues, implement improvements.
• Develop an understanding of processing equipment, including training materials and troubleshooting.
• Develop and review SOPs pertaining to Prep, Compounding and Filling.
• Drive the continues improvement in operational area.
• Trend and take appropriate actions to agreed KPI.
• Train new operators on processes and aseptic technique.
• Implement and oversee corrective actions.
• Identify potential process improvements to increase efficiency and or compliance and quality.
• Create and implement process improvements in cooperation with other operations and quality groups.
• Be the SME during internal/external audits, lead presentation and present to the auditing team.
• Independently investigate pharmaceutical operations and facility nonconformances, identifying any deviations from standards.
• Review supporting documentation including batch documentation, ancillary documentation, test results / CoAs, product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents.
• Assist with deviation/CAPA investigation and understand the process so if needed be able to take over and finalize an investigation/CAPA.
• Assist with revision to SOPs pertaining as an SME in the operating area.
• Cover for peers and manager if needed.
  
  

Minimum Qualifications

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, or related field
• 3-5 years related experience with compounding and or prefilled syringe manufacturing.
• Experience in cGMP manufacturing or clean room production environment is preferred.
  
  

Competencies/Conduct

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

• Outstanding leadership skills.
• Ability to apply analytical reasoning and root cause analysis to solve problems.
• Knowledge and hands-on experience with pharmaceutical direct and indirect utility systems, equipment, and facilities
• Understanding of lean manufacturing principles
• Ability to obtain and keep gowning certification for aseptic areas
• Strong math and calculating skills.
• Computer skills.
• Ability to read, understand, interpret, and implement technical writing and instruction as well as have exceptional abilities to problem solve in a fast-paced environment.
  
  

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

• Always act with honesty and integrity.
• 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

• Always act with honesty and integrity
• 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