Develops/implements production/processing methods and controls to meet quality standards in most cost efficient manner. Investigates and resolves work-in-process problems. Recommends and implements improvements and/or modifications in sequence of operations, equipment utilization and related matters. Monitors assigned operations to assure compliance with approved methods and standards. Degree in Manufacturing Engineering, Electrical or Mechanical. Experience in medical device industry and knowledge of CFR 820 regulation for medical devices is a must. Comprehensive understanding of Process Validation Lifecycle including Installation Qualification, Characterization and Operational / Performance Qualification. Understanding of Statistical Methods and Techniques to support validation process analyses and control plans.
|Requisitos - Requirements
Process Validations is a MUST
Minitab-knowledge is a MUST too
CSV is a PLUS
Candidates best fitted for the position are Electrical Engineers and Mechanical Engineers
More than 5 years of experience but less than 10
POINTS FOR THE POSITION:
1. Experience in Computer System Validations – Generation of CSV documentation (URS, Design/Functional Specifications, Source Code Review, FAT plan/report, IQ & OQ plans & reports)
2. Process validations – Characterizations, Process OQ & PQ, Measurement System validation
3. Documentation – Generation of Preventive Maintenance procedures, Calibration procedures, Software Back-Up and Restore procedures, Process Operation Description (SOP/POD), Work instructions
4. Good technical background, “technical know-how”, problem solving approach. Hard to assess in a resume (other than education); typically assessed in interview.