Title: Validation Scientist – Cleaning

Job Summary

Under limited direction, perform Cleaning Study, Verification, Validation and Environmental monitoring activities as mandated by cGMP’s policies/procedures and Frontida BioPharm’s quality standards and any Process Validation studies that may be necessary.  Monitor technicians, Operations and Quality personnel during swabbing activities and perform microbiological and air sampling as necessary.  Prepare FMEA (Failure Mode Effect Analysis), execution, writing reports, etc. as necessary.

Responsibilities:

  • Responsible for driving all aspects of cleaning projects and material planning
  • Execution of Cleaning Study, Verification, Validation and Environmental Monitoring activities, creating required protocols, test kits and any risk analysis documents and follow up through approval of documents
  • Calculation of the cleaning limit
  • Evaluation of data and providing primary conclusion
  • Author, review, revise or approve SOP’s or other documents as required
  • Interface with Analytical R&D, Quality Control, Manufacturing, Packaging, Logistics and Engineering to facilitate and drive documents review and approval
  • Provide cleaning support for scale-up, technology transfer and commercial projects
  • Follow cGMP’s safety procedures, DEA procedures, department SOP’s and company policies
  • Participate on cross-functional team that addresses specific problems, facilitate discussion and research, enabling procedures to become more efficient and to build and enhance interdepartmental relationships
  • Perform investigations on deviations and troubleshoot, when required
  • Prepare protocols, risk analysis and equipment schematics to ensure sampling is taken from the appropriate equipment site and testing is completed as planned.  Execute approval protocols and evaluate all microbiological and analytical data and write reports
  • Coordinate cleaning activities with company Quality Units, Operations, R&D, etc. for all Cleaning Study, Verification, Validation and Environmental monitoring activities
  • Attend team meetings as Cleaning Validation’s representative as required.
  • Follow departmental and company SOPs and policies
  • Must participate and successfully complete all training as required by the company
  • Perform other duties as assigned

Knowledge, Skills and Abilities:

 

Responsibilities

  • Responsible for driving all aspects of cleaning projects and material planning
  • Execution of Cleaning Study, Verification, Validation and Environmental Monitoring activities, creating required protocols, test kits and any risk analysis documents and follow up through approval of documents
  • Calculation of the cleaning limit
  • Evaluation of data and providing primary conclusion
  • Author, review, revise or approve SOP’s or other documents as required
  • Interface with Analytical R&D, Quality Control, Manufacturing, Packaging, Logistics and Engineering to facilitate and drive documents review and approval
  • Provide cleaning support for scale-up, technology transfer and commercial projects
  • Follow cGMP’s safety procedures, DEA procedures, department SOP’s and company policies
  • Participate on cross-functional team that addresses specific problems, facilitate discussion and research, enabling procedures to become more efficient and to build and enhance interdepartmental relationships
  • Perform investigations on deviations and troubleshoot, when required
  • Prepare protocols, risk analysis and equipment schematics to ensure sampling is taken from the appropriate equipment site and testing is completed as planned.  Execute approval protocols and evaluate all microbiological and analytical data and write reports
  • Coordinate cleaning activities with company Quality Units, Operations, R&D, etc. for all Cleaning Study, Verification, Validation and Environmental monitoring activities
  • Attend team meetings as Cleaning Validation’s representative as required.
  • Follow departmental and company SOPs and policies
  • Must participate and successfully complete all training as required by the company
  • Perform other duties as assigned

Knowledge and Skills

  • Bachelor’s Degree in Pharmacy or relevant Science/Engineering discipline.  Master’s Degree in Pharmaceutical Engineering is a plus
  • Technical understanding with equipment cleaning, microbiological and air sampling concepts
  • Computer skills (MS Word, Excel, PowerPoint)
  • Good planning and coordination skills.  Able to adapt to changes in priorities and project schedules
  • Attention to detail in documentation work and reports
  • Strong written communication skills, creativity and enthusiasm
  • Ability to work well in a team setting.  Must be able to work on multiple projects simultaneously
  • Ability to clearly present data in team meetings
  • Good knowledge of cGMP requirements and current industry practices
  • Ability to collect and interpret data, establish facts, draw valid conclusions and define problems
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