Job Description


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Equipment Qualification Engineer

  • Ref: 298281
  • Type: Direct Hire
  • Location: Fort Lauderdale, FL
  • Industry: Pharmaceuticals Manufacturers
  • Job Level: Experienced Non-Manager
  • Pay: $70,000 - $81,500

Opportunity Description

Solid Dose Pharmaceutical Equipment Qualification Engineer for 12-month contract position in Fort Lauderdale, FL. 

Job Duties

  • Develop qualification master plans, process flow diagrams, test cases, and standard operating procedures to support the manufacture of solid dose pharmaceuticals
  • Create qualification documents, functional and design specifications, test protocols (IQ, OQ, PQ), and summary reports supplementing documentation provided by suppliers/contractors/OEM’s
  • Review qualification or test plans issued by the suppliers/contractors for completeness and correctness
  • Execute test protocols including identification and resolution of non-conformances/deviations
  • Conduct qualification tests of new or existing equipment and/or software in accordance with internal protocols or external standards
  • Analyze data to perform assessment of current qualification state of equipment/facilities
  • Implement risk management and assessment techniques to highlight critical equipment, identify failure modes (FEMA) and implement strong controls for risk mitigation
  • Prepare, maintain, and/or review engineering compliance documentation such as engineering change orders, schematics, or protocols
  • Assist in training equipment operators and contractors on qualification protocols and standard operating procedures
  • Create and maintain databases to tracking qualification activities, test results and validated systems
  • Prepare detailed reports or design documents based on results of qualification tests or reviews of procedures and protocols

Experience & Skills Required

  • Required: 3-5 years of prior relevant experience validating solid dose pharmaceutical manufacturing equipment experience
  • Ability to work successfully in a team environment

Other Information