Validation Engineer

Please share your updated resume to Sravan@starkassociatesllc.com

Title : Validation Engineer

Location: San Diego /Carlsbad, CA

Duration: 12 months Contract

No. of position: 4

Job Description:

Create Master Validation plan (MVP) in coordination with different stakeholders

Hands on experience in Method Transfer, Process Validation (IQ /OQ /PQ), Validation performance and Reports.

Working on sample size determination, creating sample size for Testing’s, for Design Verification, Validation, Process Validation and Test Method Validation

Hands on experience working on Validation reports for the Manufacturing site that are moving from one place to another. This includes Facility Validation as well.

Hands on experience on drafting Protocols, Testing, Data Analysis and Test Reports

Extensive Experience on using Minitab for Data Analysis, R&R Analysis after Test Execution

Understanding on Software elements would be an added advantage

Knowledge on IVDR and DHF Remediation also will be an added advantage

Good understanding on Requirements analysis (Customer Reqs, Technical Reqs, Functional /Product Reqs), Traceability Matrix, DHF Remediation and Risk Management with FMEA working.

Experience with QC Tools and Statistical Methods

Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository

Working closely with customer counterparts and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.

Familiar with Engineering Change Orders and Engineering Change Notes

Proven track record of problem solving

Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages

Provide Project status updates to the work group, tracking the overall project implementation.

Good Communication and documentation skills. Good knowledge in MS PowerPoint and Excel