Technimates, Professionals has job openings for Sr. Validation Engineer I. Jobs located in WY and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to conduct root cause analysis and prepare CAPA. Prepare validation and performance qualification protocols for new or modified manufacturing processes (for various class I and II medical devices such as defibrillator, wheelchairs, Catheters, Scopes etc.), systems, or equipment for various production types. Utilize FDA Compliance Regulations, including CFR 210/211/820, Part 11, and

ISO 13485.

Requires hands on experience with GAMP and analytical lab instruments, including HPLC, GC, MS, FTIR, Degassers, Auto Claves, and Bio-reactors. Study product characteristics/customer requirements and confer with management to determine validation objectives and standards. Create, populate, and maintain databases for tracking validation activities, test results, and validated systems. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master's degree or foreign equivalent in Biomedical Engineering, Biological Engineering, Chemical Engineering, or related. Likely candidates will be tested on their general ability to perform the above tasks. Mail resume with cover letter to Technimates contact@technimates.com