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

Equipment Validation Engineer

Location: St Louis, MO
Job Type: Direct Hire
Salary: $70,000.00 - $90,000.00
Degree: Bachelor;
Date: 6/2/2016
Job ID: 02365470
Job Description
Title: Equipment Validation Specialists (Need 2)

Full time position … Not a contract position.

MUST have Pharmaceutical industry experience.

Equipment Validation Specialist prepare, execute, and summarize qualification protocols and other related documents (risk assessments, qualification plans, traceability matrix, periodic reviews, URS, FRS, IQ/OQ/PQ, SAT, FAT etc.) to support the equipment qualification program
  • Pharmaceutical manufacturing industry experience needed with one of the following dosage forms: Solids, Liquids, semi-solids and Capsules
  • Develop and maintain an annual plan of qualifications to be completed during each calendar year, and periodically report on progress.
  • Draft qualification protocols that meet domestic and international regulatory requirements.
  • Coordinate with maintenance and operations to develop all supporting documentation including cleaning procedures, instructions for use, maintenance work instructions and training plans.
  • Work with maintenance and operations to execute all testing on equipment and to complete the testing documentation.
  • Complete the report and draw conclusions regarding the appropriateness of the equipment for its intended use.
  • Manage the document flow for protocols, working copies and completed reports through the entire life cycle.
  • Ensure that the appropriate resources are applied to the qualification efforts.
  • Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to equipment qualification projects
  • Bachelor’s degree, preferably in a technical/science/mathematical field
  • 5+ years experience
  • Equipment qualification experience in a biotech/pharmaceutical environment.  Must be able to demonstrate direct responsibility for development, execution, and reporting