Location: Caguas, PR
Date Posted: 10-23-2017

Seeking a Engineer with regulatory previous experience in the Pharmaceutical, Biotechnology or Medical Devices Industry. Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity. The Engineer must posses regulatory experience in the Pharmaceutical, Biotechnology or Medical Devices Industry.
  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
  • Initiate and complete routine technical tasks.
Skills and Qualifications
  • Working knowledge of pharmaceutical/biotech processes.
  • Knowledge with validation processes and documentation in a highly regulated environment.
  • Knowledge in automation recipes, eBRs, and SOPs
  • Interpret and apply GLPs and GMPs and operate specialized laboratory equipment and computers as appropriate.
  • Develops solutions to routine technical problems of limited scope.
  • Specialized equipment/process expertise.
  • Completion and follow- up and Multitasking.
  • Negotiation, persuasion and facilitation, collaboration, project cost development, conflict resolution, and leadership and am building.
  • Validation protocol writing and computer literacy
  • BS in Engineering and 2+ years of experience in Pharmaceutical, Biotechnology or Medical Device Industry and previous experience with Maximo.
Integrated Technology and Compliance Services is an Equal Opportunity Employer
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