Commissioning, Qualification & Validation Specialist (CQV)

ECHO Consulting Group Inc; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

ECHO Consulting Group seeks Commissioning, Qualification, and Validation professionals to support CQV activities in regulated pharmaceutical, biotechnology, or medical device environments. This role welcomes Engineers, Scientists, and Validation Specialists with experience in equipment, utilities, laboratory systems, or facilities qualification.

Responsibilities include protocol development, execution, and validation documentation, ensuring compliance with cGMP and FDA guidelines.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Microbiology, Biology, or related field.
• 5+ years 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

• Support CQV activities.
• Develop, review, and execute IQ, OQ, and PQ protocols.
• Assist with equipment startup and commissioning activities.
• Author and review validation documentation, including protocols and reports.
• Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.
• Participate in risk assessments and impact assessments related to validation activities.
• Support change control, deviations, and CAPA investigations when required.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure compliance with GDP and data integrity principles.

Skills

CQV experience

IQ/OQ/PQ execution

Technical writing

Regulatory compliance

Data integrity knowledge

Education

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

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 Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. This role is open to Engineers, Scientists, and Validation Specialists with experience supporting equipment, utilities, laboratory systems, or facilities qualification. The selected consultant will support protocol development, execution, and validation documentation, ensuring compliance with cGMP regulations and industry standards.
Responsibilities:

• Support Commissioning, Qualification, and Validation (CQV) activities.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Assist with equipment startup and commissioning activities.
• Author and review validation documentation, including protocols, reports, and discrepancy resolutions.
• Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.
• Participate in risk assessments and impact assessments related to validation activities.
• Support change control, deviations, and CAPA investigations when required.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity principles.

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