Engineer

Descripción del Empleo:
Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team.
Generation and execution of validation plans, validation protocols (FAT/SAT/IQ/OQ/PQ/CSV’s), and completion reports. Provide statistical analysis of the date to support the reports.
Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
Review and approve validations and completion reports for new and existing products, processes and equipment.
Troubleshooting equipment/processes that do not perform as intended during validation runs.
Recommend process/quality improvements as part of validation runs.
Work with new and existing equipment, processes, utilities, facilities and cleaning validations, to include (but not limited to) freeze drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters
Requisitos:
Education and/or experience: · BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
· PE License strongly desired.
· Lean/Six Sigma Green or Black Belt Certification is a plus.
· Experience in validations such as: manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, packaging, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required.
· Minimum of 3 - 5 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years in a validation engineering position