Expertise in deviation management and investigations
The Senior Quality Engineer ensures compliance with quality standards through oversight of deviations, laboratory investigations, and Corrective and Preventive Actions
Job Summary
The Senior Quality Engineer ensures compliance with quality standards through oversight of deviations, laboratory investigations, and Corrective and Preventive Actions.
This role requires leading root cause analysis and approving CAPAs to ensure sustainability and alignment with quality systems.
Catalent offers a defined career path, 152 hours of PTO plus 8 paid holidays, and generous 401K matching benefits.
Matching Summary
The Senior Quality Engineer ensures compliance with quality standards through oversight of deviations, laboratory investigations, and Corrective and Preventive Actions.
Skills & Requirements
Must-have
Bachelor's degree in Chemistry or Engineering
8+ years pharmaceutical quality experience
Expertise in deviation management and investigations
Strong knowledge of cGMP, GLP, and ICH regulations
Experience writing and auditing Standard Operating Procedures
Nice-to-have
Preference for nasal spray formulation expertise
Knowledge of dry powder inhaler development
Ability to lead continuous improvement initiatives
Cross-functional collaboration with manufacturing teams
Key Requirements
Bachelor's degree required
Minimum 8 years relevant pharmaceutical industry experience
Must have knowledge of cGMP, GLP, and ICH guidelines