Job Summary:
This is a full time position responsible for validation equipment preparation, protocol execution and final report generation. This position will support a wide range of validation activities focused on environmental chambers, including: cryo-freezers, cold rooms, refrigerators, incubators, sterilizers, depyrogenation ovens, stability chambers, warehouses, etc. Also includes Steam in Place (SIP) validation using biological indicators. Interface with customers and equipment end users. Timely completion of projects with economic utilization of resources. Meet project objectives in a cost-effective manner.

Duties/Responsibilities:
• Pre-requisite to performing calibration procedures: signed off on General Calibration Instructions
• Perform and approve pre- and post qualification on validation sensors
• Perform calibrations incidental to validation including controllers, gauges, recorders, etc.
• Create and execute validation protocols and procedures
• Perform validation projects
• Maintain records of pertinent information for the project including project costs reconciliation
• Write, assemble, deliver and present final reports
• Relay opinions or interpretations of calibration results to customer via calibration certificates
• Train validation team members

Education/Experience Requirements:
• AS or BS in engineering or science
• 2 years validation experience in the Pharmaceutical or Biotech environment

Additional Experience/Skills:
• Kaye equipment expertise: LTR, HTR, CTR, IRTD, Kaye 2000
• Relative humidity, CO2 and pressure sensors
• Proficient with wireless technology
• ISO 9001, ISO 17025 and GMP/GLP experience
• Spreadsheet and word processing applications experience, computer literacy
• Strong written and verbal communication skills
• Strong reporting, organizational and interpersonal skills
• Multi-tasking

Physical Demands:
• Drug testing
• Inoculations specific to customer sites
• Extended travel required
• Valid driver’s license
• Work environment is office and customer sites
• Able to lift 50 lbs