Senior Validation Engineer - Indivior

TITLE:

Title:Senior Validation Engineer

Reports To:Compliance QA Manager, Raleigh

Location: Raleigh, NC

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. 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. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:

Experienced Senior Validation Engineer to provide expertise, guidance, and maintenance of the Validation activities at the Raleigh, North Carolina site as well as alignment with Global procedures to ensure compliance with FDA and other related regulations. The Senior Validation Engineer must be the subject matter expert who leads the development and implementation of systems and is the driver of continuous improvement for validation practices, policy, and procedures.

Ability to be impactful and influence people/areas in matters related to GxP compliance and regulatory adherence.

A strong leader with respect to being a positive influence to support the growth of the organization as well as team members.

This role requires excellent change management skills and the ability to work in a fast-moving dynamic organization.

ESSENTIAL FUNCTIONS:

The Senior Validation Engineer will perform requalification and qualification of equipment and or processes within the facility.  They will participate in FAT, SAT, engineering studies and commissioning activities.

The Senior Validation Engineer will be a senior member of the validation team developing, reviewing, executing, and managing validation activities, and ensuring that the qualification/validation activities are consistent with user's/manufacturer's requirements and site quality standards.

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

• Author validation protocols and final reports.
• Execute requalification and validation protocols.
• Organize and maintain validation documentation.
• Schedule and track projects for timely delivery.
• Calibration of instrumentation and the use of a Kaye Validator System/temperature mapping.
• Work in all areas of the Raleigh manufacturing plant with experience in aseptic gowning.
• Maintain qualified equipment systems in compliance with policies, guidelines, and procedures.
• Execute and/or lead installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.
• Manage changes, deviations, investigations, and CAPAs via TrackWise/Veeva Vault.
• Maintain and manage positive working relationships while assisting in all stages of change management.
• Review and participate in process validation, FMEA, and project remediation.
• Develop validation protocols (IQ/OQ/PQ), write test scripts, user requirements and lead process validation activities for various manufacturing processes.
• Assess change controls, facility work orders and equipment risk assessments to ensure compliant/validated state of all GMP equipment and systems.
• Interact with FDA investigators regarding cleaning validation, equipment qualifications with respects to compliance issues and regulatory requirements.
• Streamline procedures for equipment/utility qualification and CSV using risk assessment and standardization.
• Well versed in GMP/GXP procedures and validation requirements and experienced at gathering technical information from vendors and user requirements. 
• Working knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.

MINIMUM QUALIFICATIONS:

License/Certifications: N/A

Bachelor’s degree in science or engineering field or equivalent experience. 

Five to seven years of experience in pharmaceutical validation, production, engineering, environmental monitoring, quality control, mechanical or related fields are preferred.  Ability to learn new processes and equipment independently is required.  Must be proficient in Microsoft applications i.e. Word, Excel/formula builds. 

Travel: Approximately 10% travel.

COMPETENCIES/CONDUCT:

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

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.
• A plus to have experience in developing qualification protocols for laboratory instruments utilize for QC analytical and microbiological testing purposes.

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 discount 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 and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Leverage Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gym, fitness facility and cell phone discounts
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

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