BAS & HVAC Validation Engineer – GMP/FDA Compliance

Mentor Technical Group; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Mentor Technical Group seeks an experienced BAS Validation Engineer to support qualification and validation activities for Building Automation Systems, HVAC, environmental monitoring, and GMP facility infrastructure. The role includes validating systems like Siemens Desigo CC and ensuring compliance with FDA regulations, GAMP 5, data integrity, and site quality procedures.

You will author IQ/OQ/PQ protocols, develop validation plans, URS, risk assessments, and traceability matrices, and

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• 3+ years in validation, commissioning & qualification in GMP environments.
• Experience executing IQ/OQ/PQ protocols; knowledge of BAS/BMS, HVAC, GAMP 5, FDA regulations.

Responsibilities

• Develop and execute IQ, OQ, and PQ protocols.
• Author and review validation documents (Plans, URS, Risk Assessments, Traceability, VSR).
• Validate BAS/BMS and HVAC systems; support change controls, deviations, CAPA.

Skills

Documentation

Technical writing

Collaboration

Regulatory compliance

Education

Bachelor's degree

Tools

Siemens Desigo CC

IQ/OQ/PQ protocols

Job description

Mentor Technical Group seeks an experienced BAS Validation Engineer to support qualification and validation activities for Building Automation Systems, HVAC, environmental monitoring, and GMP facility infrastructure. The role includes validating systems like Siemens Desigo CC and ensuring compliance with FDA regulations, GAMP 5, data integrity, and site quality procedures.

You will author IQ/OQ/PQ protocols, develop validation plans, URS, risk assessments, and traceability matrices, and