Location
Menlo Park, CA, United States
Posted on
Apr 07, 2021
Profile
We are seeking a Validation Engineer III for a very important client.
Requirement:
We are seeking a Validation Engineer III for a very important client.
The ideal candidate will possess the following qualifications:
Candidates must possess 3-7 years experience supporting validation programs and possess a BS degree, preferable in the Science or Engineering fields (or equivalent experience). Give attention to detail, perform critical analysis of situations and provide recommendations, work independently with structured guidance, good follow up skills
Validations, process validations Med device is a Plus Protocols/reports Abilitiy to to learn mechanical processes Good writing skills Statistical analysis 50 onsite/ 50 remote nonlocal is okay. Desire a Mechanical engineer if possible 5-7 years preferable experience Will take other types of engineers (Materials, Biomedical, chemical, etc) and lower experience 4 yrs min as long as they are driven and quick learners. Fast pace environment to meet our deadlines Medical device experience a plus (our products are very mechanical and polymer based) Worked with Catheter Processes a PLUS (understand various equipment and processes) Key attributes Quick learner, mechanical aptitude, understand statistics analysis, flexible, driven, good communicator (written and verbal) Will be working on re-validating our products Need to be able to quickly learn the process and create process validation draft protocols, initiate the builds and testing and analysis/reports: Many documents and testing is needed to be generated to support the business need Writings skills are critical,(MS Word , Powerpoint typically used) Statistical analysis (JMP, Minitab are some of programs typically used) is needed (must be a quick learner if not) Understand process development so they can understand the processes being validated (critical inputs/outputs) KEY WORDS: Process Validation Operational Qualifications Process Qualifications DOE (Design of experiment) Equipment Qualifications (IQ/OQ) Process Development Statistical Analysis Medical Devices
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