Sr. Quality Engineer, Validations

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Job Summary

The Sr. Quality Engineer, Validations provides technical and quality leadership in the planning, execution, and lifecycle management of validation programs covering Facilities, Utilities, Equipment, and Process (FUEP) in alignment with the Site Master Validation Plan (MVP). This role ensures that all validated and qualified systems supporting Pharmaceutical (Rx), OTC, and Cosmetic manufacturing operate in a state of control, and remain compliant with FDA 21 CFR Parts 210, 211, 820, and 11, EU Annex 15, ICH Q7-Q10, and GAMP 5 guidelines.

The Sr. QE partners cross-functionally with Quality, Operations, Engineering, and Maintenance to manage validation and process qualification projects, strengthen process capability, enhance equipment reliability, and uphold Crown’s Quality Systems through technical accuracy, risk-based validation, and data integrity excellence.

Sr. Manager, QA Technical Services

Johnson City, TN - onsite

• Develop, execute, and approve Validation Master Plans (VMPs), User Requirement Specifications (URS), Design/Configuration Specifications (DS/CS), Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and Validation Summary Reports (VSRs) in support of the Master Validation Plan.
• Lead Process Validation (PV) lifecycle activities, including Process Design, Process Qualification (PPQ), and Continued Process Verification (CPV), ensuring alignment with ICH Q8/Q9/Q10 and FDA PV Guidance (2011).
• Author and review Process Validation Protocols, define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), and apply statistical analysis to confirm process capability (Cpk/Ppk).
• Develop and maintain Requirements Traceability Matrices (RTMs) linking user requirements, risk assessments, and qualification test outcomes.
• Execute testing for Facilities, Utilities, Equipment, and Process, including HVAC, WFI/RO water systems, compressed air, autoclaves, incubators, filling lines, and compounding equipment.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and qualification transition for new or modified systems.
• Maintain validation deliverables in compliance with cGDP and ALCOA+ data integrity principles.

• Lead and execute Stage 1-3 Process Validation following FDA and ICH guidance, including process characterization, PPQ strategy development, and ongoing verification.
• Partner with Manufacturing and QA to ensure validated processes consistently produce material meeting predetermined specifications and quality attributes.
• Perform data trending, statistical analysis, and process capability studies to monitor validated processes and identify opportunities for improvement.
• Support Continued Process Verification (CPV) by maintaining control charts, analyzing deviations and trends, and providing periodic validation reviews.
• Ensure all process validation documentation is current, traceable, and readily available for inspection.

• Author and support Change Controls, Engineering Studies, CAPAs, and Deviation Investigations associated with validation and process changes.
• Establish procedural and system controls to sustain validated and qualified states; document alarm limits and critical control points.
• Contribute to the development and maintenance of Validation SOPs, Work Instructions, and Templates to standardize validation activities.

• Coordinate communications among Quality, Operations, Engineering, and Maintenance to ensure timely execution of validation and process qualification projects.
• Provide technical validation guidance to project teams and ensure inspection readiness during internal, corporate, and regulatory audits.
• Lead validation-related meetings, track milestones, and communicate project progress to management and stakeholders.

• Apply risk-based engineering principles and GAMP 5 methodologies to enhance process and equipment performance, reduce variability, and improve…