Indivior
Senior Validation Engineer (Finance)
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:
In addition to the minimum qualifications, the employee will demonstrate:
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:
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:
EQUAL EMPLOYMENT OPPORTUNITY