Validation Engineer

Job title: Aseptic Process Validation Engineer II Location: Houston TX (onsite) Duration: 18 months Interviews: 2We are unable to provide sponsorship at this moment.Job Description:Supports and collaborates with the project team for validation efforts right from inception, design build, test and implementationInvestigate/troubleshoot validation discrepancies for systems and/or performance processesSupport validation activities – IQ/OP/PQSupport ethylene oxide requalification activities to meet ISO requirements on timeCreate change controls and provide assistance in determining root cause for non-conforming events and evaluate CAPAs for effectivenessEnsures required processes and procedures are followed to support validation programs and are in compliance with regulationsCo-operates with all departments through open, candid communication and collaborationPrior experience working with ethylene oxide and gamma sterilization processes Pharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to the medical devices and surgical.Knowledge of statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.EEO:“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.” Thanks in advance for your time and consideration, please feel free to provide a current version of your resume. I look forward to hearing from you!