Process Validation Engineer


Sarver, PA

Industry: IT Consulting/Services


5 - 7 years

Posted 267 days ago

  by    Cynet EngineeringTeam

This job is no longer available.

We are looking for ????Process Validation Engineer for our client in Sarver, PA

Job Title: Process Validation Engineer

Job Location: Sarver, PA

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

Job Description:

  • Min 5year of exp


  • 3+ years of 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

Primary Skills:

  • Project Management
  • 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