Validation Engineer

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 built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate leaders who will define tomorrow and partner with clients in the food & beverage, life sciences, industrial, and advanced technology industries to shape 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. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has grown into a $3 billion organization with nearly 12,000 team members, united by a common belief : to use the power of business to build a better world. Job Description : Validation Engineer Who You’ll Work With You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work closely with clients on impactful projects. You will be welcomed into a rapidly growing business and team, empowered to make an impact, and supported in your professional growth. Our environment values your success and fulfillment, surrounded by leaders dedicated to your development. As a Validation Engineer II at Design Group, you will work with industry experts to solve complex problems for leading companies. You will join our Regulatory Compliance Practice, collaborating with seasoned leaders and technical specialists to deliver high-quality, consistent solutions to our clients. What You’ll Do Support capital projects and implement solutions for clients, helping improve performance and achieve goals. Develop and execute validation and FDA compliance documents / protocols for pharmaceutical equipment, including FAT, SAT, IQ, and OQ documentation for automated systems. Assist in developing and executing QMS procedures, ICH Q1 (Stability Protocols / Reports), CFR 21 Parts 211 & 820, ICH Q8, Q9, and Q10. Perform investigations and troubleshoot validation issues. Prepare validation reports and communicate findings effectively. Travel to client sites as needed for installation, start-up, and project activities. What You’ll Bring Strong communication and interpersonal skills, with flexibility and ability to interact with all management levels, clients, and vendors. At least 3 years of project experience in validation of automation, packaging, utilities, or facilities. Experience in pharmaceutical, biotechnology, or medical device environments is a plus. Experience in gown-room environments is a plus. Proficiency in technical writing and oral communication. Strong computer skills (Microsoft Office, Project, AutoCAD). Willingness to travel as required for project needs. B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related field. Our culture fosters mutual respect, integrity, and collective success. We offer professional development resources, mentorship, and a rewarding, flexible career path. We encourage applicants from diverse backgrounds and provide accommodations during the interview process. Barry-Wehmiller is an equal opportunity employer. We use E-Verify and may conduct pre-employment screenings including drug tests, background checks, and skills assessments. Additional Responsibilities : Establish validation standards, develop protocols, report findings, and oversee resolution of compliance issues. Maintain validation documentation, including specifications, SOPs, and testing records. Ensure compliance with external regulations and standards. Assist with equipment purchases or upgrades as needed. Perform other duties as assigned. #J-18808-Ljbffr