Sr. Quality Engineer

About the role

The Senior Quality Engineer will act as the primary technical resource for Quality Engineering across facilities, utilities, maintenance, and engineering (FUME) projects in a GMP pharmaceutical/biologics environment. The role supports 24/7 operations, ensuring compliance, data integrity, and continuous improvement.

Key responsibilities

• Provide senior technical guidance on FUME‑related projects, equipment qualification, and commissioning.
• Review and approve qualification and commissioning documentation to meet GMP standards.
• Monitor utility performance, trend data, and escalate excursions.
• Execute maintenance, engineering, qualification, and quality activities as assigned.
• Lead investigations, perform Root Cause Analysis (RCA), and support CAPA implementation.
• Facilitate risk assessments, FMEA studies, and other quality risk‑management initiatives.
• Draft, route, and maintain audit‑defensible documentation in line with Good Documentation Practices (GDP) and data‑integrity requirements.
• Coordinate change‑control activities across impacted functional areas.

Required profile

• Bachelor’s degree in Engineering or a related discipline.
• Minimum five years of Quality Engineering experience in GMP pharmaceutical or biologics manufacturing, preferably supporting API operations.
• Bilingual proficiency in Spanish and English (written and verbal).
• Willingness to work irregular hours, shift rotations, weekends, holidays, and emergency situations.

Required skills

• GMP pharmaceutical/biologics manufacturing knowledge.
• Experience with Facilities, Utilities, Maintenance, and Engineering (FUME) systems.
• Commissioning, qualification, and validation processes.
• Root Cause Analysis (RCA) and CAPA execution.
• Change control and risk management (FMEA preferred).
• Good Documentation Practices (GDP) and data‑integrity principles.
• Proficiency with Microsoft Office.
• Familiarity with quality systems such as TrackWise, Veeva, QMS, Kneat, or similar platforms.