CQV Specialist — Drive cGMP Validation & Compliance

ECHO Consulting Group Inc; Carolina (PR); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

ECHO Consulting Group, Inc. is seeking CQV professionals to support validation activities in regulated pharmaceutical, biotechnology, or medical device manufacturing environments. Open to Engineers, Scientists, and Validation Specialists with IQ/OQ/PQ experience.

The selected consultant will develop, execute, and review protocols and validation documentation, ensure cGMP compliance, and collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams in Carolina, PR.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Experience in validation, QA/ CQV

cGMP knowledge

Technical writing

Educación

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

Descripción del empleo

ECHO Consulting Group, Inc. is seeking CQV professionals to support validation activities in regulated pharmaceutical, biotechnology, or medical device manufacturing environments. Open to Engineers, Scientists, and Validation Specialists with IQ/OQ/PQ experience.

The selected consultant will develop, execute, and review protocols and validation documentation, ensure cGMP compliance, and collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams in Carolina, PR.