CQV Lead

ECHO Consulting Group; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Technical writing

Regulatory compliance

Collaboration

Documentation

Education

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

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

We are seeking a qualified and detail-oriented Utilities & Facilities Qualification Engineer to support commissioning, qualification, and validation activities within a regulated pharmaceutical manufacturing environment. The successful candidate will plan, execute, and document qualification activities for critical utilities, facility systems, and associated equipment while ensuring compliance with current Good Manufacturing Practices (cGMP), approved procedures, and applicable regulatory requirements.

Responsibilities:

• 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.

Shift: Administrative (Available to work or provide support to a 24/7 manufacturing operation, as required)

Location: Manati

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

Preferred Qualifications:

• 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.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.