Validation Engineer

Job DescriptionValidation EngineerLocation: Beloit, WI Contract: 3+ month duration contract role ONSITESponsorship is not available for this role now or in the futureAutomated Systems, Inc. is actively recruiting for a Validation Engineer with one of our global client’s Pharmaceutical Manufacturing Facility located in Beloit, WI. In this job role, the Validation Engineer will be tasked with assisting in establishing Commissioning and Qualification (C&Q) policies/strategies, lead specific C&Q activities for pharmaceutical manufacturing equipment and processes, ensure compliance with quality standards/requirements, and industry standards (FDA, EMA, ISO, ICH, etc.). The Validation Engineer will help drive C&Q project completion and compliance in a challenging and fast-moving environment in a timely and efficient manner.Duties And ResponsibilitiesAssists in the change management of facilities, utilities, systems, equipment (FUSE), and processes. Assists in developing and managing the C&Q Programs/Processes including generating and maintaining site and project C&Q plans. Overseeing C&Q schedules/activities, and coordinating various C&Q activities with cross functional teams. Work with cross-functional teams in design reviews, impact assessments, generation of requirements, risk assessments, and other identified C&Q deliverables. All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards. Education, Experience And Skill Requirements Bachelor’s degree in engineering or a Science-related field. 3+ years of progressive experience in the pharmaceutical industry with at least 2 of those years acting in a Qualification/Validation role. Experience working with current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment is necessary. Demonstrated proficiency in five or more validation areas required. Experience with Statistical Analysis preferred. - Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment. Proficient in Word, Excel, and PowerPoint. Knowledge of GMP and understanding of validation and pharma guidelines. Company DescriptionWe are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.