Pharma Clean Utilities Engineer – Commissioning & Validation

MMR Consulting; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

MMR Consulting is seeking a senior engineer to lead design, commissioning and qualification activities for pharmaceutical and biopharmaceutical facilities and utilities. You will guide project teams through validation deliverables, coordinate field activities and ensure compliance with regulatory requirements.

The role involves working on client sites, developing validation plans, and mentoring junior staff while coordinating with cross-functional teams across North America and Asia.

Qualifications

• 5+ years of experience in commissioning, qualification or validation of clean utility systems in pharma/biotech.
• Experience in cGMP operations and pharmaceutical/biotech requirements.
• Knowledge of water systems, PW/WFI/CS and HVAC utilities.
• Experience with validation approaches (ASTM E-2500 or ISPE ICQ) is an asset.
• Leadership and mentorship capabilities are desirable.

Responsibilities

• Provide technical guidance for design, installation, commissioning, qualification and start-up of pharma facilities and utilities.
• Develop deliverables such as PFDs, P&IDs, specs, equipment layouts, DQ/IQ/OQ/PQ plans and checklists.
• Support field installation and field execution of test cases and protocols.
• Serve as SME on clean utilities design and operation and regulatory readiness.
• Lead project lifecycle activities to meet quality, schedule and budget.

Skills

Leadership

Mentorship

Multi-tasking

Project management

Communication

Education

Engineering degree (Mechanical/Electrical/Chemical)

Job description

MMR Consulting is seeking a senior engineer to lead design, commissioning and qualification activities for pharmaceutical and biopharmaceutical facilities and utilities. You will guide project teams through validation deliverables, coordinate field activities and ensure compliance with regulatory requirements.

The role involves working on client sites, developing validation plans, and mentoring junior staff while coordinating with cross-functional teams across North America and Asia.