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Manufacturing Systems Training Lead

Title: Manufacturing Systems Training Lead

Reports To: Associate Director – Manufacturing Systems & Controls

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 the chronic conditions and co-occurring disorders of OUD. Indivior is 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 over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

The Manufacturing Systems Training Lead is a key position to support the Indivior Raleigh Manufacturing site with hands-on expertise in the use and operation of critical systems like MES (Mfg. Execution Systems), EBR (Electronic Batch Records), E-Logbooks, and EM (Environmental Monitoring) systems. This will include creating training content for operators and engineers using the Apprentice-Tempo and Ignition platforms. In addition to the systems training and support, the role will also support engineering/automation teams with equipment troubleshooting and process improvements as well as support with system deviations and CAPAS as applicable.

ESSENTIAL FUNCTIONS:

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

• Configure, Troubleshoot, and support MES (Apprentice-TEMPO) software applications and systems.
• Manage the development of production recipes and devising automation solutions that improve productivity, business operations and safety/quality standards.
• Work and support, as needed, the Engineering and Automation teams to support Mfg. with controls issues.
• Validate new systems and changes to existing systems.
• Support Engineering with Systems Deviations and CAPA’s.
• Audit and update existing system documentation and procedures like SOP’s and Work Instructions.
• Drive new releases & hot fixes technical assessments and related interoperability test with MES software.
• Find innovative ways to leverage MES to drive business value.
• Identify areas of improvement in the automation code and/or EBR (Electronic Batch Record) to improve efficiency.
• Strong Communication skills.
• Experience with PLC’s, preferably Rockwell AB.
• Strong Electrical background, especially low voltage signal analysis.
• Knowledgeable in ACAD and Visio.
• Understanding Windows Operating systems and Virtual Machines.
• Network communication understanding.
• Other duties as assigned

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in engineering or related field from an accredited university
• Minimum 10 years of MES/SCADA/PLC experience in a relevant manufacturing environment.
• Experience with SQL databases, scripting, and report generation.
• Hands-on experience with AB PLCs and SCADA systems and FactoryTalk Studio.
• Experience in Wonderware SCADA.
• General awareness and knowledge of security and quality requirements (privacy & GxP)
• Experience in troubleshooting and debugging MES/SCADA control systems
• Knowledge of API integration and system connectivity
• Understand EBR interfaces with other ERP systems and LIMS Systems
• Hands-on experience in Inductive Automation’s Ignition SCADA/Historian and Apprentice Tempo MES/EBR platform, this includes Operations Management, Suite Installation, Configuration, Solution Designing, Implementation, SAT, Qualification, and Site Support
• Possess complex recipe-authoring expertise and practical experience in end-to-end recipe creation
• Managing software release lifecycle & processes
• Global object development and management
• Escalation points for support (monitoring platform, DB, system health, troubleshooting servers, resolving network/firewall issues etc.)
• Strong cGMP, GAMP (Good Automated Manufacturing Practices) knowledge and Data Integrity preferred
• Pharmaceutical Manufacturing support experience, either from a process or engineering aspect preferred

COMPETENCIES/CONDUCT:

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

• Understanding of S88 & S95 Standard & control system
• Understanding of Electrical principles applied to controls (AC – DC current)
• Knowledge of data management concepts and practices
• Technical skills in SQL language
• Demonstrated ability to evaluate, facilitate, and drive toward risk-based decision-making
• Ability to thrive in a complex, changing virtual environment across multiple sites
• Ability to manage projects and maintain project schedules

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