Validation Engineer


: $114,590.00 - $168,140.00 /year *

Employment Type

: Full-Time


: Engineering

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We are looking for Validation Engineer for our client in Austin, TX Job Title Validation Engineer Job Location Austin, TX Job Type Contract Job Description FDA inspection experience as an SME interface. Develop and track validation related metrics (e.g. Validation Master Plan). Provide validation training and consultation services on validation policies and practices. Work closely with engineering and quality personnel providing expertise and guidance for verifying and validating new products and processes. Provide guidance on defining the validation and verification strategy, including risk management mitigations, verification, and validation plans, protocols, and reports. Provide risk management training and facilitation for FMEA and control plan development sessions. Review, analyze, and provide recommendations for verification and validation test data. Provide guidance on resolving deviations and ECO associated with verification and validation activities. Evaluate validation reports to ensure compliance with ISO and FDA regulation requirements. Provide ISO 13485 and FDA regulation guidance (specifically CFR 820). Verify the validation activities as a dedicated subject matter expert to ensure the validation processes fully comply with ISO and FDA regulations requirements. Primary Skills Knowledgeable in statistical rationale and sampling plans. Experience creating verification and validation strategy, plans, protocols, and reports. Experience with Project Managing Process Validation in a Medical Environment (Execution Master Validation Plans for a Medical program). Understanding of the operations and validation of facilities and utilities Familiarity with PCBA and sub-assembly production processes. Familiarity with automated assembly and manual processes Strong SPC skills, control plan, and FMEA experience. Good knowledge of quality and process control systems. Experience and working knowledge with ISO13485 and or FDA regulations. Secondary Skills Six-Sigma, Lean, MiniTab. Educational Qualifications B.S Degree in Technical or Engineering Practice. * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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