Business Development Director, CSV

Overview

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. We combine deep domain expertise in the manufacturing environment with an approach built to serve the dynamic needs of our clients. Our culture centers on Truly Human Leadership, cultivating leaders who will define tomorrow and partner with 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. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become 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:

Director of Compliance & Validation, Life Sciences

You will join one of our 45 offices in the US, be part of a committed team of over 1,500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Director of Compliance & 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.

• Lead a team of validation professionals and interface with clients
• Provide subject matter expertise in the validation of a variety of utility, facility, and process equipment
• Develop project scope statements, estimates, and proposals
• Lead regional business development efforts and expand engagements with existing clients
• Work on multiple projects simultaneously
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

• A minimum of ten years of experience with increasing responsibility in validation/quality service and project management of life sciences, biotech, or other FDA regulated projects
• Project management experience involving scope, budget, schedule, quality, risk, and client management
• Diverse experience leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation (preferred)
• The ability to read engineering documents and experience in proposal development
• A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred)
• An understanding of good documentation practices, cGMP, and FDA validation methods and systems
• A working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance, and the latest industry expectations for data integrity
• Strong project management software and word processing skills, and solid technical writing skills
• A passion for a career in the life science industry
• Experience in mentorship, multi-discipline collaboration, and in a consulting and service environment
• A willingness to travel for project requirements including project installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars,…