Senior Engineer - GMP Validation & Automation Lead

Mirus Consulting Group; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico seeks a Senior Engineer to support commissioning, qualification, and lifecycle management for manufacturing equipment and systems within a regulated pharmaceutical environment.

The successful candidate will provide technical leadership for projects involving parenteral products manufacturing, vision inspection systems, device assembly, and packaging operations, including automatic and High-Mix Low-Volume production lines.

Qualifications

• Doctorate or Master's/Bachelor's with engineering experience in regulated environments.
• Experience with equipment qualification, validation, and manufacturing processes.
• Strong knowledge of GMP and regulatory standards.

Responsibilities

• Lead commissioning, qualification, and validation for manufacturing equipment and systems.
• Develop, execute, and approve IQ/OQ/PQ protocols and related docs.
• Support parenteral manufacturing processes ensuring GMP compliance.
• Assist start-up and optimization of vision inspection systems in pharma/medical device ops.
• Lead device assembly and packaging equipment, including automatic and HMLV lines.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, and Regulatory Affairs.
• Support investigations, change controls, CAPAs, deviations, and risk assessments.
• Evaluate equipment performance and identify process improvements and efficiency gains.
• Ensure activities meet safety, quality, and compliance requirements.

Skills

GMP knowledge

Engineering leadership

Commissioning

Qualification protocols (IQ/OQ/PQ)

Parenteral manufacturing

Vision inspection systems

Education

Doctorate in Engineering

Master's Degree in Engineering + 2 years experience

Bachelor's Degree in Engineering + 4 years experience

Job description

mîrus Consulting Group in Humacao, Puerto Rico seeks a Senior Engineer to support commissioning, qualification, and lifecycle management for manufacturing equipment and systems within a regulated pharmaceutical environment.

The successful candidate will provide technical leadership for projects involving parenteral products manufacturing, vision inspection systems, device assembly, and packaging operations, including automatic and High-Mix Low-Volume production lines.