Senior CQV Validation Specialist — Pharma/Med Devices

ECHO Consulting Group Inc; Manatí (PR); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CQV experience

IQ/OQ/PQ execution

Technical writing

Regulatory compliance

Data integrity knowledge

Educación

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

Descripción del empleo

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.