Technical Services - Cleaning Validation

Be the First to Apply

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Technical Services - Cleaning Validation

Job Description

Cleaning Validation Technician

Department: Technical Services - Cleaning Validation

Location: Sellersville, PA

Reports To: Manager/Senior Scientist, QA- Cleaning Validation

Position Summary

The Cleaning Validation Technician supports the execution of cleaning validation, cleaning verification, and monitoring activities for manufacturing and packaging equipment. The position is responsible for equipment sampling, documentation, data collection, and coordination of cleaning validation studies to ensure compliance with cGMP, FDA, and company requirements.

Cleaning Validation Technician

Department: Technical Services - Cleaning Validation

Location: Sellersville, PA

Reports To: Manager/Senior Scientist, QA- Cleaning Validation

Position Summary

The Cleaning Validation Technician supports the execution of cleaning validation, cleaning verification, and monitoring activities for manufacturing and packaging equipment. The position is responsible for equipment sampling, documentation, data collection, and coordination of cleaning validation studies to ensure compliance with cGMP, FDA, and company requirements.

Key Responsibilities

• Perform cleaning validation and cleaning verification sampling activities, including swab and rinse sampling of manufacturing and packaging equipment.
• Execute cleaning validation protocols, monitoring studies, and clean/dirty hold time studies.
• Coordinate sampling activities with Manufacturing, Quality Control, and Quality Assurance departments.
• Complete and maintain accurate GMP documentation, laboratory notebooks, forms, protocols, and reports.
• Perform equipment inspections and verify equipment readiness for sampling activities.
• Assist in execution of cross-contamination assessments, cleaning investigations, and CAPA activities.
• Support maintenance of validated equipment lists and cleaning validation databases.
• Collect, organize, and trend cleaning validation data for ongoing monitoring programs.
• Assist in preparation, revision, and periodic review of SOPs and validation documents.
• Support regulatory inspections, client audits, and internal audits by providing cleaning validation documentation and technical support.
• Maintain compliance with site safety policies and GMP requirements.

Education and Experience

• Associate's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering Technology, or related scientific discipline preferred.
• High school diploma/GED with relevant GMP pharmaceutical experience may be considered.
• 1-3 years of experience in pharmaceutical manufacturing, validation, laboratory, or quality systems preferred.
• Experience with cleaning validation, equipment qualification, sampling, or GMP documentation is desirable.

Knowledge, Skills, and Abilities

• Knowledge of cGMP, FDA, ICH, and pharmaceutical quality requirements.
• Understanding of cleaning validation principles, equipment cleaning processes, and contamination control.
• Ability to follow protocols and SOPs with a high degree of accuracy.
• Strong documentation and data recording skills.
• Proficiency with Microsoft Office applications.
• Ability to work independently and collaboratively in a cross-functional team environment.
• Strong organizational, communication, and problem-solving skills.

Physical Requirements

• Ability to work in manufacturing and warehouse environments.
• Ability to wear required PPE.
• Ability to climb ladders, access equipment platforms, and perform equipment swabbing activities.
• Ability to lift up to 25 pounds and stand for extended periods during sampling activities.