Senior Quality Engineering Specialist

We are seeking an experienced Senior Quality Engineering Specialist to support quality and compliance activities in a GMP-regulated pharmaceutical manufacturing environment. This role will provide quality oversight for engineering, facilities, utilities, maintenance, and qualification activities, ensuring compliance with quality standards and regulatory requirements.

Key Responsibilities

• Support quality engineering activities related to equipment, facilities, utilities, and manufacturing processes.
• Review and manage qualification, commissioning, maintenance, and engineering documentation.
• Lead or support investigations, root cause analyses (RCA), CAPAs, and change control activities.
• Participate in risk assessments and continuous improvement initiatives.
• Monitor compliance with GMP, GDP, and data integrity requirements.
• Support inspection readiness and internal audit activities

Bachelor's degree in Engineering or a related technical/scientific field.

Minimum of 5 years of Quality Engineering experience in pharmaceutical, biotechnology, or biologics manufacturing.

Comprehensive knowledge of Facilities, Utilities, Maintenance and Engineering (FUME) standards.

Proficiency with Quality Systems and computer platforms (e.g., Microsoft Office, TrackWise, Veeva QDocs, QMS,

Kneat, GMARS). Preferred: hands-on experience with change control and investigations/CAPA processes

Bilingual in English and Spanish