Senior Quality Engineer - Facilities & Equipment

Job DescriptionJob Description

Position: Senior Quality Engineer – Facilities & Equipment

Location: North Carolina
Type: Full-Time
Schedule: Standard business hours, Monday–Friday
Compensation: $140,000 – $150,000 annually

Overview

This role provides quality leadership for facility infrastructure, equipment systems, and related processes at a pharmaceutical manufacturing site. The Senior Quality Engineer will oversee preventive maintenance, calibration, qualification, and validation activities to ensure systems operate in a compliant and controlled state. The position also drives continuous improvement projects to reduce compliance risks and strengthen operational readiness for regulatory inspections.

Core Responsibilities

• Serve as the quality lead for facilities, equipment, and associated processes, ensuring compliance with regulatory and internal quality standards.
• Evaluate and approve engineering changes to critical systems, ensuring impact assessments and documentation meet quality requirements.
• Support system validation, equipment qualification, and commissioning activities, including review and approval of related protocols and reports.
• Partner with operations, engineering, and maintenance teams to resolve equipment or system-related issues, implement corrective and preventive actions, and identify areas for process improvement.
• Manage investigations of deviations, out-of-specification (OOS) results, and complaints linked to facility or equipment performance.
• Monitor quality metrics for critical systems and use data to drive improvement initiatives.
• Maintain up-to-date knowledge of applicable regulatory guidelines (cGMP, FDA, USP, ISO, ISPE) and integrate them into operational practices.
• Prepare and present compliance documentation during regulatory inspections.
• Provide training to staff and mentor junior engineers on quality processes for equipment and facility systems.

Qualifications

• Bachelor's degree in engineering, life sciences, or a related technical discipline.
• 5–8 years of experience in pharmaceutical manufacturing or a similarly regulated industry, with a focus on quality systems and validation.
• Strong understanding of FDA regulations, cGMP, 21 CFR Part 210, 211, 11, USP, ISO 13485/14644, and ISPE guidelines.
• Hands-on experience with quality documentation, root cause analysis, risk assessment, and CAPA processes.
• Knowledge of aseptic processing, continuous improvement methodologies (Six Sigma, Lean, DMAIC), and electronic quality systems (e.g., TrackWise, Documentum) is .
• Excellent communication, documentation, and problem-solving skills with proven ability to lead projects and collaborate across functions.
• Certification in CQE or Six Sigma Black Belt is an advantage.
• Willingness to travel up to 20% as needed.