Head of Compliance Projects

Project Manager, Validation page is loaded## Project Manager, Validationlocations: East Brunswick, NJtime type: R020999BW 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. Job Description:**Project Manager, Validation**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 in teams and directly with our clients doing work that is shaping the world around us. When you join Design Group as a Project Manager, Validation, 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 Do**You'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 preparing, executing commissioning and qualification documents for a variety of utility, facility, and process equipment.* Lead and manage a diverse portfolio of validation projects simultaneously (equipment qualification, process validation, cleaning validation, system digitization, etc.)* Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.* Serve as the primary on-site point of contact and local engineering leader for major pharmaceutical manufacturing clients* Build and maintain strong relationships with client stakeholders across operations, quality, regulatory, and executive levels* Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team**What You’ll Bring*** Minimum 10+ years of demonstrated experience with validation of pharmaceutical or medical device processes and equipment* FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry* Validation experience in the areas of automation, packaging, cleaning, Computer systems, utilities and/or facilities is desired* Excellent leadership skills including the ability to simultaneously organize, and successfully execute multiple project responsibilities* Candidates need to possess good communication and interpersonal skills and the ability to interact with all levels of management, clients, and vendors.* Strong computer skills are also required* Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.* Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent technical degree.Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path.