Senior Engineer, Validation

Indivior • Raleigh, NC

1d • $88,000 - $105,000 • Onsite

About The Position

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.

Requirements

• 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.
• Well-versed in GMP/GXP procedures and validation 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.

Nice To Haves

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.
• 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 authority.
• Ability to work independently to deliver outputs and through others as required.
• Attention to detail and great organization skills.
• Adept IT skills and ability to learn quickly.

Responsibilities

• Perform requalification and qualification of equipment and or processes within the facility.
• Participate in FAT, SAT, engineering studies and commissioning activities.
• Develop, review, execute, and manage validation activities, and ensuring that the qualification/validation activities are consistent with user's/manufacturer's requirements and site quality standards.
• 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.
• Gather technical information from vendors and user requirements.

Benefits

• Competitive PTO plus company closure from December 24th- January 1st
• Eligible to participate in Indivior’s bonus program, based on company and individual performance
• Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan
• 401(k) and Profit-Sharing Plan- Company match
• 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
• Wellness programs as well as other discounts and perks

What This Job Offers

• Job Type: Full-time
• Career Level: Senior