Cleaning Validation Specialist

ECHO Consulting Group•Juncos, PR

About The Position

ECHO Consulting Group provides solutions for the pharmaceutical, biotechnology, medical device, and food industries, including CQV, quality management, regulatory compliance, manufacturing support, and project management. The company describes a workplace centered on trust, respect, teamwork, creativity, enthusiasm, and diligence, and offers competitive compensation and professional development. The Cleaning Validation Specialist coordinates cleaning validation activities and prepares and executes protocols and reports for cleaning development and validation. The role performs cleaning validation on the manufacturing floor, supports sampling and sample management, investigates cleaning-related incidents and deviations, and collaborates with Quality Assurance, Manufacturing, and Engineering. The position is located in Juncos, Puerto Rico, and may support first-, second-, and third-shift schedules as project and business needs require.

Requirements

Minimum of 5 years of professional cleaning validation experience in the pharmaceutical and biotechnology industries.
Bachelor’s degree in science or engineering is preferred.
Knowledge of cleaning validation, continuous process improvement, and troubleshooting processes.
Experience with the validation sample management lifecycle.
Strong project management, time management, planning, and organizational skills.
Proficiency in risk assessment and management.
Proven assessment, analytical, and problem-solving skills.
Proficient presentation, technical writing, and oral communication skills in English.
Proficiency in cGMPs, OSHA, and FDA regulations as applicable to the pharmaceutical industry.
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.
Effective communication and cross-functional collaboration skills.
Ability to work independently and manage multiple priorities.
Proficiency with KNEAT.
Leadership and teamwork skills; self-starter, results-oriented, and able to build and maintain relationships with multiple groups.

Responsibilities

Support authoring and execution of CV/CHT/SHT protocols, progress package work, and completion of executed studies.
Support non-traditional work schedules based on project and business needs.
Support the cleaning validation program using drug substance process equipment, autoclaves, parts washers, and CIP skids.
Use PI for run-trending analysis and facilitate completion of support packages.
Lead and perform on-floor cleaning validation execution and sampling.
Provide technical support and sample management for cleaning activities associated with manufacturing.
Design and develop cleaning procedures for new products and manufacturing equipment.
Conduct cleaning validation studies, including sampling, testing, and data analysis.
Investigate and troubleshoot cleaning-related incidents, deviations, and out-of-specification results for non-validated or under-development cleaning procedures; perform root-cause analysis.
Support periodic reviews of cleaning validation studies.
Resolve incidents and deviations related to cleaning validation exercises successfully and on time.
Collaborate with Quality Assurance, Manufacturing, and Engineering to integrate cleaning validation activities into project plans.
Train manufacturing and QC/QA personnel on cleaning validation documentation.
Prepare and execute protocols and reports for cleaning development and validation.