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Business: Piramal Pharma Solutions
Department: Technical Services
Location: Sellersville
Job Overview:-
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
REPORTING STRUCTURE: Reports to Director, Technical Services
KEY ROLES/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.
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