Senior Quality Engineer

Catalent • Durham, NC

4d • Onsite

About The Position

The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing.
The Senior Quality Engineer is responsible for ensuring compliance with quality standards and regulatory requirements through effective oversight of deviations, laboratory investigations, and Corrective and Preventive Actions (CAPAs). This role requires extensive experience, sound judgment, and the ability to lead quality improvement initiatives.

Requirements

• Must have a bachelor’s degree. Preferably in Chemistry, Engineering or Pharmaceutical Science
• Minimum of 8+ years of relevant experience in the pharmaceutical industry, specifically within a Quality function role is required
• Strong knowledge of deviation management, investigations, and CAPA systems with Strong communication and leadership abilities is required
• Must have knowledge of cGMP, GLP, ICH, and compendial regulations or guidelines
• Experience writing, amending and auditing Standard Operating Procedures is required
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Nice To Haves

• Strong expertise across multiple dosage forms, with a preference for nasal spray formulations is preferred

Responsibilities

• Review, approve, and provide guidance on deviations, ensuring thorough root cause analysis and appropriate corrective actions
• Lead and support laboratory investigations to ensure accuracy, completeness, and compliance with internal procedures and regulatory expectations
• Evaluate and approve CAPAs for effectiveness, sustainability, and alignment with quality systems
• Monitor and analyze quality data to identify negative trends and drive continuous improvement initiatives
• Proactively recommend and implement process improvements to enhance product quality and operational efficiency
• Collaborate cross-functionally with manufacturing, quality control, and regulatory teams to resolve quality issues
• Other duties as assigned

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees