Cleaning Validation Specialist

Job Description

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.