Cleaning Validation Specialist

American Health Packaging; Juncos (PR); On-site; USD 75,000 - 95,000; Full time

Job summary

American Health Packaging seeks a Cleaning Validation Specialist to coordinate cleaning validation activities, prepare protocols, and execute studies in Juncos, Puerto Rico. The ideal candidate has over 5 years of experience in the pharmaceutical industry, proficiency with KNEAT, and strong project management skills.

This role supports crucial cleaning procedures and requires excellent communication abilities, compliance with cGMP standards, and strong problem-solving skills.

Qualifications

• 5+ years of experience in cleaning validation in pharmaceutical/biotech industries.
• Proficient with cGMP's, OSHA, and FDA regulations.
• Strong understanding of GMPs and global regulatory expectations.

Responsibilities

• Coordinate and execute cleaning validation protocols and reports.
• Perform technical support and sample management for cleaning activities.
• Conduct troubleshooting and root cause analysis of cleaning-related incidents.

Skills

Knowledge of cleaning validation

Project management skills

Technical writing skills

Analytical and problem-solving skills

Risk Assessment/Management

Education

Bachelor’s in science, Pharmacy or Engineering

Tools

KNEAT

Job description

Cleaning Validation SpecialistSkip to main contentWe use cookies and tracking technologies to offer you a better browsing experience, analyze site traffic, and improve the website.# AmerisourceBergen is now Cencora! Explore our careers.Cleaning Validation Specialist page is loaded## Cleaning Validation SpecialistApplylocations: Juncos, Puerto Rico: Carolina, Puerto Ricotime type: Full timeposted on: Posted Todayjob requisition id: R269397Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details****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* Supports 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:** Administrative shift and willing to provide services during non admin. hours, based on project needs**Location:** Carolina, PR / Juncos, PR**Education:** Bachelor’s in science,Pharmacy 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 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 KNEATThis position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.