Cleaning Validation Specialist

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 is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations/discrepancies.

Responsibilities:

• Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies

• Support non-traditional work schedule based on project and business needs
• Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
• Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Proficient with KNEAT execution
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
• Supports the periodic review of cleaning validation studies.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.

Shift: 1st, 2nd, and 3rd Shift

Location: Juncos, PR

Education: Bachelor’s in Science or Engineering

Preferred Qualifications:

• Minimum of 5 years of professional experience in cleaning validation in the pharmaceutical and biotechnology industries.
• Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
• Validation Sample Management lifecycle experience
• Strong project management skills.
• Proficient time management skills, planning and organization capabilities.
• Proven leadership & teamwork skills, self-starter, results-oriented, and build and maintain strong relationships with multiple groups.
• Proficiency in Risk Assessment/Management
• Proven assessment, analytical, and problem-solving skills.
• Proficient presentation skills and Technical Writing/Oral communication skills (English)
• Proficient in cGMP's, OSHA, and FDA Regulations as it applies to the pharmaceutical industry.

Skills:

• Strong understanding of GMPs and global regulatory expectations.
• Ability to interpret equipment design, P&IDs, and process flow diagrams.
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities.
• Effective communication and cross-functional collaboration.
• Ability to work independently and manage multiple priorities.
• Proficient with KNEAT

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.