Process Validation Scientist

4/20/21

Toms River, NJ 08701

1215

FullTimeRegular

The Process Validation Scientist will be responsible for being the primary statistical process control data analyst and technical problem solver for processes entering the commercial production phase of their process lifecycle. This role may have other process validation responsibilities as assigned, but will primarily retrieve process data, analyze the data, look for positive and adverse trends, correlate the findings, solve technical issues as noted by the data analysis for process improvement/ refinement, and create written reports about the exercise.

This person has developed a core competency in process validation and processes from the GMP scale production during late phase clinical runs through PPQ campaigns, and commercial campaigns, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Technical Support associates/scientists.

Responsibilities:

  • Perform all functions associated with process validation support, specifically focusing on Continued Process Verification (CPV).
  • Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes).
  • Make recommendations for process changes and sponsors these to the larger process team.
  • Provide data, analyses, write-ups, reviews, and other input to annual product reviews (APR)
  • Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem-solving tools e.g. Fish-Bone (Ishikawa), Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
  • Represent Process Validation on project teams and interfaces with customer technical and Quality representatives once a project has reached commercialization. Represents Process Validation on internal teams (e.g. Deviation and project management meetings).
  • Participate in Customer and Regulatory Audits. Regularly interact with site leadership on matters concerning several functional areas and/or customers.
  • Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results.

Qualifications:

Education
Bachelor’s degree is required in Chemical or Mechanical Engineering or Statistics or Pharmaceutical Sciences. Other engineering or science degree considered based on relevant work experience.

Experience

  • 4+ years of Pharmaceutical industry experience in commercial scale manufacturing operations.
  • 4+ years of experience with large scale process validation and/or manufacturing support
  • In depth knowledge of current Good Manufacturing Practices and US/EU regulations.
  • Knowledge of basic statistical analyses such as T-tests, F-tests, box-plots, understanding p values, process capability, ANOVA, etc. as well as control charting, Nelson’s/Shewart’s rules (or other statistical trending rules), etc. is required
  • Basic knowledge of statistical analysis and familiarity with a mainstream statistical software analysis program such as MiniTab and/or JMP as well as an intermediate knowledge of process validation principles and their application in pharmaceutical manufacturing is required

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