Weil Group, Inc
JOB DESCRIPTION
Simplrea project
Role & Requirements
Availability to work extended shifts (8‑12 hours per shift)
Availability to work weekends (Saturday and/or Sundays)
Availability to work holidays as required
Availability to work first and/or second shift (if required), mainly first shift
Minimum 2 years experience in Process Validation and Computer System Validations
1 Quality Engineer (QE) from Client will approve all documentation
Use Client Quality Systems & Validation Templates
Education & Experience
Engineering Degree (Mechanical, Electrical or Chemical preferred)
Years of experience: 2+ years in validation process
Position will be onsite/full‑time
Must Have
Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
Basic knowledge in defining validation strategies (e.g., requirements flow down from design to manufacturing)
Experience with Risk management documentation: pFMEAs
Basic knowledge in statistics (preferably using Minitab)
Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence)
Engineering degree: Mechanical, Electrical or Chemical preferred
Preferences
Experience investigating manufacturing operations events in support to product disposition
Experience assessing and tracing manufacturing defects/rejects trends
Knowledge in Medical Devices regulations
Experience working and executing Design transfer activities
Weil Group is proud to be an Equal Employment Opportunity Employer.
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Role & Requirements
Availability to work extended shifts (8‑12 hours per shift)
Availability to work weekends (Saturday and/or Sundays)
Availability to work holidays as required
Availability to work first and/or second shift (if required), mainly first shift
Minimum 2 years experience in Process Validation and Computer System Validations
1 Quality Engineer (QE) from Client will approve all documentation
Use Client Quality Systems & Validation Templates
Education & Experience
Engineering Degree (Mechanical, Electrical or Chemical preferred)
Years of experience: 2+ years in validation process
Position will be onsite/full‑time
Must Have
Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
Basic knowledge in defining validation strategies (e.g., requirements flow down from design to manufacturing)
Experience with Risk management documentation: pFMEAs
Basic knowledge in statistics (preferably using Minitab)
Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence)
Engineering degree: Mechanical, Electrical or Chemical preferred
Preferences
Experience investigating manufacturing operations events in support to product disposition
Experience assessing and tracing manufacturing defects/rejects trends
Knowledge in Medical Devices regulations
Experience working and executing Design transfer activities
Weil Group is proud to be an Equal Employment Opportunity Employer.
#J-18808-Ljbffr