Commissioning, Qualification & Validation Specialist (CQV)

ECHO Consulting Group; United States; On-site; USD 95,000 - 125,000; Full time

Job summary

ECHO Consulting Group, Inc. seeks Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in regulated pharmaceutical, biotechnology, or medical device manufacturing environments.

This role welcomes 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

Qualifications

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

• 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, 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 GDP and data integrity principles.

Skills

5+ years validation experience

Technical writing

Documentation skills

Education

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

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: Carolina, PR

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.