CQV Specialist: Validation, Compliance & Startup Support

ECHO Consulting Group; Carolina (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

ECHO Consulting Group is seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in regulated environments. Open to Engineers, Scientists, and Validation Specialists with experience in equipment, utilities, laboratory systems, or facilities qualification.

The selected consultant will help develop, execute, and document protocols (IQ/OQ/PQ) while ensuring cGMP compliance and adherence to GDP and data integrity standards. Bachelor's degree required.

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

• Support CQV activities in a regulated pharmaceutical/biotech/medical device environment.
• 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, FDA guidelines, GDP, and data integrity principles.
• 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.

Education

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

Job description

ECHO Consulting Group is seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in regulated environments. Open to Engineers, Scientists, and Validation Specialists with experience in equipment, utilities, laboratory systems, or facilities qualification.

The selected consultant will help develop, execute, and document protocols (IQ/OQ/PQ) while ensuring cGMP compliance and adherence to GDP and data integrity standards. Bachelor's degree required.