R.A. Wylan & Co. Inc.,
Career Center

Process Validation Specialist

Location: St Louis, MO
Job Type: Direct Hire
Salary: $70,000.00 - $90,000.00
Date: 3/8/2016
Job ID: 02287075
Job Description
Title: Process Validation Specialist 
Full time position … Not a Contract position.
MUST have Pharmaceutical industry experience.

Prepare, execute, and summarize validation protocols and other validation related documents (risk assessments, validation plans, traceability matrix, periodic reviews etc.) to support the process validation program.
  • Pharmaceutical manufacturing industry experience needed with one of the following dosage forms: Solids, Liquids, semi-solids and Capsules
  • Provide compliance leadership, direction, and oversight in the area of Process Validation.
  • Develop and maintain an annual plan of process validations to be completed during each calendar year, and periodically report on progress.
  • Investigate manufacturing processes and formulas to identify historical challenges and critical control points in the process.
  • Draft validation protocols that meet domestic and international regulatory requirements.
  • Coordinate with Supply Chain, Operations and Scale Up department to plan manufacturing of required batches and to set timelines for execution.
  • Coordinate with Quality Control to develop testing regimens and frequencies, and to plan for stability or other special studies.
  • Support Operations during execution of the validation studies, being present during the manufacturing as often as required.
  • Complete the report and draw conclusions regarding the fitness of the people, equipment, process and controls to properly execute formula instructions.
  • Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to Process Validation projects
  • Bachelor’s degree, preferably in a technical/science/mathematical field
  • 5+ years experience
  • Validation experience in a biotech/pharmaceutical environment, specializing in Process Validation.  Must be able to demonstrate direct responsibility for development, execution, and reporting.