Validation Engineering Tech

About Us:BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. Validation Engineer IIWho You’ll Work WithYou will join one of our 45 offices in the US, be part of a committed team of over 1600 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. When you join Design Group as a Validation Engineer II, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.What You’ll DoYou'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.Responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. This person will travel to top clients across the country to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals. Establish user requirement specification for critical equipment and systemsAssess risk across various aspects of systems’ functions and focus efforts on critical quality aspectsDevelop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes including: Process Equipment, Facility / Utilities, Cleaning / ProcessWork with teams to perform investigations and troubleshoot issues related to validationAnalyze qualification data and recommend corrective actionsDevelop & perform impact assessments, trace matrices, system risk assessments, and other risk-based validation documentation deliverablesPrepare validation reportsAssist in project planning, scheduling, and coordinationProvide routine communication and status updates to BW Design Group project leadership and the client. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and teamWhat You’ll BringCandidates need to possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendorsAbility to work as an individual contributor as well as a team player on a large project teamMinimum of 3 years project experience in the pharmaceutical or medical device environmentsStrong technical writing and oral communicationsStrong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)Willing and able to travel as necessary for project requirements to include but not limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.Understanding of ICH Q7 through 11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, and ASTME2500B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Validation Engineer II, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First-Year Experience program, Individual Development Plans, and Career Path resources and tools. Indianapolis, INType: Full time