Senior Validation Scientist

12/22/22

Sellersville, PA

1885

Senior Validation Scientist

Position Summary

The Senior Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale[1]up, process optimization, process/packaging validation as well as routine commercial production support, equipment qualification and cleaning validation.\

Responsibilities

  • Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation, equipment qualification and cleaning validation 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 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 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 activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
  • Independently develop and/or execute experimental designs and approaches to resolve complex 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 Company clients.
  • Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures

Qualifications

  • Minimum of a Bachelor’s degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 5 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 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 multiple projects independently 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.
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