CQV Lead: Pharma Utilities & Facilities Expert

ECHO Consulting Group; Puerto Rico; Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

ECHO Consulting Group in Manati, Puerto Rico seeks a Utilities & Facilities Qualification Engineer to support commissioning, qualification, and validation activities in a regulated pharmaceutical manufacturing environment.

You will plan, execute, and document qualification for critical utilities and facility systems, ensure cGMP compliance, and collaborate with Engineering, QA, Manufacturing, Maintenance, Automation, Validation, and external contractors to deliver projects safely and on

Qualifikationen

• 5+ years of experience in validation, commissioning, qualification, or regulated manufacturing environments.
• Knowledge of cGMP regulations and validation lifecycle.
• Experience supporting IQ/OQ/PQ execution or validation documentation.
• Strong technical writing and documentation skills.

Aufgaben

• Develop, review, and execute commissioning and qualification protocols, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support the qualification and periodic review of critical utility systems such as HVAC, purified water, Water for Injection (WFI), clean steam, compressed gases, process gases, electrical systems, and building management systems.
• Support facility qualification activities for manufacturing areas, laboratories, cleanrooms, warehouses, and controlled environments.
• Prepare and review User Requirements Specifications (URS), risk assessments, traceability matrices, test scripts, qualification reports, and system turnover packages.
• Apply risk-based qualification principles in accordance with approved site procedures and industry standards.
• Investigate protocol deviations, identify root causes, assess product and compliance impact, and coordinate corrective and preventive actions.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Maintenance, Automation, Validation, and external contractors to complete projects safely and on schedule.
• Review engineering drawings and technical documentation, including P&IDs, layouts, specifications, equipment data sheets, and vendor documentation.

Kenntnisse

Technical writing

Regulatory compliance

Collaboration

Documentation

Ausbildung

Bachelor’s degree in Engineering, Chemistry, Microbiology, Biology, or related scientific discipline

Jobbeschreibung

ECHO Consulting Group in Manati, Puerto Rico seeks a Utilities & Facilities Qualification Engineer to support commissioning, qualification, and validation activities in a regulated pharmaceutical manufacturing environment.

You will plan, execute, and document qualification for critical utilities and facility systems, ensure cGMP compliance, and collaborate with Engineering, QA, Manufacturing, Maintenance, Automation, Validation, and external contractors to deliver projects safely and on