Senior Engineer, Validation
Indivior
August 29, 2026
On-site
Raleigh, NC
Operations
Responsibilities:
- Provide expertise, guidance, and maintenance of validation activities at Raleigh, NC; align with Global procedures for FDA and related regulatory compliance.
- Lead development, implementation, and continuous improvement of validation practices, policies, and procedures.
- Perform requalification and qualification of equipment/processes; participate in FAT, SAT, engineering studies, and commissioning.
- Author IQ/OQ/PQ protocols and final reports; write test scripts and user requirements; lead process validation.
- Execute requalification/validation protocols; organize/maintain validation documentation; track projects for on-time, compliant delivery.
- Use Kaye Validator System (or equivalent) for temperature mapping; gown into aseptic areas.
- Maintain qualified equipment systems; lead installation/commissioning, SIP/CIP process validation, environmental chamber qualification, and critical process utility qualification.
- Manage changes, deviations, investigations, and CAPAs via Veeva Vault; support CAPA/change resolution.
- Review process validation, FMEA, and remediation; assess change controls/work orders/equipment risk assessments.
- Interface with FDA investigators on cleaning validation and equipment qualification.
- Streamline equipment/utility qualification and CSV using risk assessment and standardization.
Qualifications/Skills:
- BS in science or engineering (accredited).
- 5+ years preferred in production, engineering, environmental monitoring, QC, mechanical, or related fields; learn new processes/equipment independently.
- Proficient in Microsoft Word/Excel; strong communication.
- Knowledge of QA/QMS methods (FMEA, Pareto, Six Sigma concepts); plus experience for lab instrument qualification.
- Working knowledge of GMP/GxP validation; process automation and CSV; GAMP; CFR Part 11 electronic records/signatures; data integrity expectations.
- Ability to work cross-functionally; independent and detail-oriented.
- Travel ~10%.
Benefits (explicit): Starting salary $88,000–$105,000; PTO incl. company closure Dec 24–Jan 1; bonus eligibility; 401(k) w/ match; medical/dental/vision/life/disability; tuition reimbursement; adoption assistance; other listed incentives.
- Provide expertise, guidance, and maintenance of validation activities at Raleigh, NC; align with Global procedures for FDA and related regulatory compliance.
- Lead development, implementation, and continuous improvement of validation practices, policies, and procedures.
- Perform requalification and qualification of equipment/processes; participate in FAT, SAT, engineering studies, and commissioning.
- Author IQ/OQ/PQ protocols and final reports; write test scripts and user requirements; lead process validation.
- Execute requalification/validation protocols; organize/maintain validation documentation; track projects for on-time, compliant delivery.
- Use Kaye Validator System (or equivalent) for temperature mapping; gown into aseptic areas.
- Maintain qualified equipment systems; lead installation/commissioning, SIP/CIP process validation, environmental chamber qualification, and critical process utility qualification.
- Manage changes, deviations, investigations, and CAPAs via Veeva Vault; support CAPA/change resolution.
- Review process validation, FMEA, and remediation; assess change controls/work orders/equipment risk assessments.
- Interface with FDA investigators on cleaning validation and equipment qualification.
- Streamline equipment/utility qualification and CSV using risk assessment and standardization.
Qualifications/Skills:
- BS in science or engineering (accredited).
- 5+ years preferred in production, engineering, environmental monitoring, QC, mechanical, or related fields; learn new processes/equipment independently.
- Proficient in Microsoft Word/Excel; strong communication.
- Knowledge of QA/QMS methods (FMEA, Pareto, Six Sigma concepts); plus experience for lab instrument qualification.
- Working knowledge of GMP/GxP validation; process automation and CSV; GAMP; CFR Part 11 electronic records/signatures; data integrity expectations.
- Ability to work cross-functionally; independent and detail-oriented.
- Travel ~10%.
Benefits (explicit): Starting salary $88,000–$105,000; PTO incl. company closure Dec 24–Jan 1; bonus eligibility; 401(k) w/ match; medical/dental/vision/life/disability; tuition reimbursement; adoption assistance; other listed incentives.