Process Validation Engineer

  •  

Sarver, PA

Industry: Engineering Services

  •  

Not Specified years

Posted 297 days ago

  by    Bajrang Yadav

This job is no longer available.

Job Title: Process Validation Engineer

Location: Sarver,PA

 

Overview:

'

? hands-on experience in validation engineering with medical devices

? Hands-on Experience with process validation

?Experience in Statistical process control (SPC), Design of Experiments (DoE), Process control Plans, Sampling methodologies, MSA/GR&R, & statistical data analysis

? Hands on experience in leading & executing process validation(IQ/CQ,OQ,PQ)

?Experience in authoring & reviewing validation protocols

?Experience in manufacturing/validation documentation

? Demonstrated experience in Mitigating, identifying, and resolving manufacturing and test method issues (NCR/CAPA)

?Experience in root cause investigation for validation failures, manufacturing issues, or design issues

?Experience in Agile & Minitab

? Green Belt/Black Belt certification preferred

? Good understanding of medical device (21CFR 820 & ISO13485) regulatory standards and engineering applications

 

 KeyWORDS: Process validation(IQ, OQ, PQ), Statistical process control (SPC), Design of Experiments (DoE), Process control Plans, Sampling methodologies, MSA/GR&R, & statistical data analysis

 

Primary Skills:

'1. Project Management

2.Proces validation (Medical Devices IQ, OQ and PQ)

 

Secondary Skills:

'Good Communication and interpersonal skills.

Project Management skills.

Spanish Language must

 

Educational Qualifications

BE-Mechanical 

$80K - $150K