Senior Cleaning Validation Specialist – Pharma QC

ECHO Consulting Group; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

ECHO Consulting Group in Juncos, PR seeks a Cleaning Validation Specialist to coordinate and execute CV activities across projects. You will prepare protocols, investigate deviations, and provide technical support for GMP-compliant cleaning validation efforts.

Responsibilities include leading on-floor CV execution, sample management, and developing procedures for new products and equipment, with collaboration across QA, Manufacturing, and Engineering.

Qualifications

• Minimum of 5 years of professional experience in cleaning validation in pharmaceutical/biotech industries.
• Proficient knowledge of cleaning validation, continuous improvement and troubleshooting processes.
• Validation sample management lifecycle experience.
• Strong project management skills and leadership abilities.
• Excellent time management, planning, and organizational skills.
• Proven ability to collaborate with QA, Manufacturing and Engineering.

Responsibilities

• Coordinate and execute CV/CHT/SHT protocols and reports.
• Investigate deviations and discrepancies related to cleaning validation.
• Lead floor CV execution, sampling and sample management.
• Develop cleaning procedures for new products and equipment.
• Perform cleaning validation studies including sampling and data analysis.
• Conduct root cause analysis of cleaning incidents and out-of-spec results.
• Support periodic reviews of cleaning validation studies.
• Collaborate with cross-functional teams to integrate CV activities into projects.
• Train manufacturing and QA personnel on CV documentation.

Skills

GMP knowledge

Analytical skills

Problem solving

Effective communication

Cross-functional collaboration

Project management

Time management

Leadership & teamwork

Risk assessment

Regulatory knowledge (FDA/cGMP)

Technical writing

Independent work

Education

Bachelor’s in Science or Engineering

Tools

KNEAT

Job description

ECHO Consulting Group in Juncos, PR seeks a Cleaning Validation Specialist to coordinate and execute CV activities across projects. You will prepare protocols, investigate deviations, and provide technical support for GMP-compliant cleaning validation efforts.

Responsibilities include leading on-floor CV execution, sample management, and developing procedures for new products and equipment, with collaboration across QA, Manufacturing, and Engineering.