Commissioning, Qualification & Validation Specialist (CQV)
About The Position
ECHO Consulting Group is seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in regulated pharmaceutical, biotechnology, or medical device manufacturing environments. The 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 while ensuring compliance with cGMP regulations and industry standards. The position is located in Carolina, Puerto Rico, and has an administrative shift. The specialist must be available to work or provide support to a 24/7 manufacturing operation as required. A bachelor's degree in Engineering, Chemistry, Microbiology, Biology, or a related scientific discipline is required. ECHO Consulting Group describes itself as a provider of solutions for the pharmaceutical, biotechnology, medical device, and food industries, and emphasizes trust, respect, teamwork, creativity, enthusiasm, diligence, quality, collaboration, and results.
Requirements
- Bachelor's degree in Engineering, Chemistry, Microbiology, Biology, or a related scientific discipline.
- Experience supporting equipment, utilities, laboratory systems, or facilities qualification.
- Support protocol development, execution, and validation documentation in a regulated manufacturing environment.
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
