Commissioning, Qualification & Validation Specialist (CQV)
About The Position
ECHO Consulting Group is seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. The role is open to engineers, scientists, and validation specialists with experience supporting qualification of equipment, utilities, laboratory systems, or facilities. The selected consultant will support protocol development, execution, and validation documentation, helping ensure compliance with cGMP regulations and industry standards. The position has an administrative shift and may require providing support to a 24/7 manufacturing operation as needed. The location is Manatí. ECHO Consulting Group provides solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. The company describes a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence, and offers competitive compensation and professional development. ECHO Consulting Group is an equal opportunity employer.
Requirements
- Bachelor’s degree in Engineering, Chemistry, Microbiology, Biology, or a related scientific discipline.
Nice To Haves
- Five or more years of experience in validation, commissioning, qualification, or regulated manufacturing environments.
- Knowledge of cGMP regulations and the validation lifecycle.
- Experience supporting IQ/OQ/PQ execution or validation documentation.
- Strong technical writing and documentation skills.
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.
Benefits
- Competitive compensation package
- Professional development
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What This Job Offers
Job Type
Full-time
