Validation Specialist I

The Validation Specialist I should have experience in validation life cycle and will also contribute intermediate to advanced level of pharmaceutical support skills under scientific and administrative direction.Apply sound scientific methods and analysis while communicating and collaborating across levels.Responsible for providing technical support such as manufacturing support, regulatory documentation and continued process verification.Responsible for providing the necessary technical support to assure timely manufacturing of pharmaceutical products in compliance with cGMP's, safety and environmental regulations, and site standards and policies.Provides ideas and works on implementation of other continuous improvement, lean and compliance initiatives.Use tools and systems to achieve product/process robustness and compliance excellence.Requisitos:Bachelor's Degree in Pharmaceutical Science, Natural Sciences, Engineering or related science.Minimum 3 years of experience in a pharmaceutical industry role with hands on experience in technical operations and/or process support role.Working knowledge with cGMPs and regulatory requirements as they apply to the pharmaceutical industry is a must.Technical knowledge proficiency in manufacturing process to actively participate in problem solving and continuous improvement initiatives directly related to production areas.Technical writing experiences related to complex investigations of manufacturing processes and protocols.Experience in deviation management, troubleshooting and resolving manufacturing trends.Experienced with formal problem solving techniques, such as root cause analysis, FMEA, CAPA establishment and Lean/Six Sigma tools is required.Strong interpersonal and communication skills.Fully Bilingual (English and Spanish).Computer Skills (Microsoft Office & Proj