3 engineering jobs found in Tampa, FL

Validation Engineer needed w/Master's deg or Foreign Equiv in Engg Mgmt or Mechanical Engg & 1 yr exp as Validation Engineer performing following job duties: Dvlp strategy for commissioning & qualification work for facility & utility systems. Write commissioning & qualification protocols for facility & utility systems & summary reports. Execute commissioning & qualification activities. Write & revise URSs for facility & utility systems. Dvlp maintenance plans for facility & utility systems. Work w/ metrology for dvlpg calibration plans for instruments associated w/ facility & utility systems. Perform dsgn review for utility & facility systems. Perform Walkthroughs w/ drafter & internal engineer to verify drawings of systems. Write SOPs/BOPs reqd for sampling for utility & facility systems. Job Locations: Tampa, FL or unanticipated client sites w/in the U.S. Must be available to travel & relocate to unanticipated client...

Sr. Validation Engineer needed w/Master's deg or Foreign Equiv in Engg Mgmt or Mechanical Engg or Process Engg & 1 yr exp as Sr. Validation Engineer or Validation/Packaging Engineer performing following job duties: Analyze & review key validation deliverables, such as validation plans, risk assessments & validation summary reports, ensuring full compliance w/21 CFR Part 11, GAMP 5 & GMP FDA Regs. Ensure adherence to Regulatory & industry stds throughout the project lifecycle. Review, approve & execute key validation docs, incl User Reqmt Specs (URS), Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) protocols. Investigate validation deviations, implmt Corrective and Preventive Actions (CAPA), perform comprehensive risk assessments & maintain the Reqmt Traceability Matrix (RTM) to ensure compliance w/ regulatory standards & internal procedures. Prep, execute & doc Factory Acceptance Testing (FAT)...

Quality Engineer Design & develop med. devices. Responsible for quality oversight, assy design, risk management & all compliance. Skills in CAPA, EU MDR, GAP Analysis+ MS in Electrical Eng. required. Travel to unanticipated clients' sites Mail to Job Loc: The Fountain Group, LLC 3407 W. Martin Luther King Jr. Blvd. #150, Tampa FL 33607 recblid tmn0ujls44pa374jagr0h9f4kj6zzc