Senior Engineer, GMP Compliance & C&Q Lead

Mirus Consulting Group; Juncos (PR); On-site; USD 110,000 - 145,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, is seeking a Senior Engineer to lead commissioning, qualification, and characterization of manufacturing, utility, facility, and laboratory systems within a regulated pharma/biotech environment, ensuring GMP compliance with FDA/EMA standards.

This role collaborates across Engineering, Quality, Manufacturing, Validation, Supply Chain, and external vendors to ensure systems are designed, installed, tested, and operated to approved requirements

Qualifications

• Education credentials require a doctorate or master's with related experience.
• Bachelor's degree with 4+ years related experience.
• Master's with 2+ years related experience.

Responsibilities

• Lead C&Q strategy and planning.
• Oversee commissioning and qualification activities.
• Coordinate IQ/OQ/PQ documentation.
• Ensure GMP, FDA, and EMA compliance.
• Collaborate with cross-functional teams.
• Mentor junior engineers and manage projects.

Skills

Risk assessment

Regulatory compliance

Project leadership

Technical writing

Quality systems

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Job description

mîrus Consulting Group, based in Humacao, Puerto Rico, is seeking a Senior Engineer to lead commissioning, qualification, and characterization of manufacturing, utility, facility, and laboratory systems within a regulated pharma/biotech environment, ensuring GMP compliance with FDA/EMA standards.

This role collaborates across Engineering, Quality, Manufacturing, Validation, Supply Chain, and external vendors to ensure systems are designed, installed, tested, and operated to approved requirements