Commissioning, Qualification & Validation Specialist (CQV)

ECHO Consulting Group; Carolina (PR); On-site; USD 80,000 - 140,000; Full time

Job summary

ECHO Consulting Group is seeking 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 validating equipment, utilities, laboratory systems, or facilities.

You will participate in protocol development, execution, and validation documentation, and ensure compliance with cGMP

Qualifications

• 5+ years of validation, commissioning, or regulated manufacturing experience.
• 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 for validation projects.
• 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 and FDA guidelines.
• Participate in risk assessments and impact assessments related to validation.
• Support change control, deviations, and CAPA investigations.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure GDP and data integrity principles.

Skills

CQV experience

Technical writing

Regulatory compliance

Education

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

Job description

ECHO Consulting Group is a highly successful and growing consulting company serving the Healthcare industry. We offer professional development, training, competitive compensation, and a stimulating, collaborative work environment. Our core services span validation, quality management & regulatory compliance, manufacturing support, and project management. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

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 : Multiple locations

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 this Echo Consulting Group, Inc. depends solely on your qualifications.