Validation Scientist

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. EXPERIENCE: * Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry. * Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulators, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc. * Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidances, and general compliance expectations. * Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing. * Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data. * Technical writing experience is required with attention to detail skills essential. * Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills. * Must have proficiency in the Microsoft Office Suite programs. * Demonstrated professionalism and excellent communication skills with internal and external personnel are essential. * Ability to work effectively managing multi projects at a fast pace with cross-functional departments and manage priorities to meet timelines. * Must be innovative, proactive, resourceful and committed to continuous improvement. * Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred

Created: 2026-04-02