Validation Scientist

Piramal • Sellersville, PA

3d

About The Position

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support

Responsibilities

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed