Senior Engineer, Validation

Senior Engineer, Validation WHO WE ARE 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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally. POSITION OVERVIEW 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, implementation and is the driver of continuous improvement for Indivior's 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. Ability to work in a fast-moving dynamic organization with excellent change management skills. HOW YOU'LL MAKE AN IMPACT 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 (IQ/OQ/PQ) and final reports, write test scripts, user requirements and lead process validation activities for various manufacturing processes Execute requalification and validation protocols. Organize and maintain validation documentation. Track projects for timely delivery and consistency with regulatory requirements. Use of a Kaye Validator System or equivalent temperature mapping instruments. Ability to gown into aseptic areas. Maintain qualified equipment systems in compliance with policies, guidelines, and procedures. Execute and/or leads 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 Veeva Vault. Maintain and manage positive working relationships while assisting in all stages of CAPA and change management and resolution. Review and participate in process validation, FMEA, and project remediation. 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 respect to compliance issues and regulatory requirements. Perform deviation investigations and help to implement CAPA and re-validation as necessary. Streamline procedures for equipment and utility qualification and CSV using risk assessment and standardization. Well-versed in GMP/GXP procedures and validation requirements and experience 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. WHAT YOU'LL BRING Bachelor's degree in science or engineering field from an accredited university. A minimum of five (5) years of experience in 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. 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. Ability to work in a team and cross-functionally when required. Good communication skills, written and oral. Developing influential skills in areas with no direct reporting au #J-18808-Ljbffr indivior