Technical Services – Cleaning Validation

Piramal Pharma Ltd•Sellersville, PA

3d•Onsite

About The Position

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.

Requirements

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 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.

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.