Job Description

Apply

Submit Email

If you've inquired to HumanEdge in the past, please use the same email to help shorten the inquiry process. If you've never inquired or don't remember, you may use any valid email address.

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

INDNJ #ZR3