Director, Compliance and Validation

Join to apply for the Director, Compliance and Validation role at BW Design Group
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You will join our Indianapolis office, one of our 45+ U.S. locations, and become part of a dedicated team of over 1,500 professionals. In this role you will work with clients and cross‑functional teams to shape solutions that transform the world. You will be welcomed into a rapidly growing business where you are empowered, valued, cared for and challenged on your path to becoming a world‑class consultant.

• Lead a team of validation professionals and interface with clients
• Provide subject‑matter expertise in the validation of various 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
• Ensure project objectives are met
• Make an impact day‑to‑day with your skills and expertise, strengthening relationships with clients and teams

• 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
• Experience developing business and client relationships
• 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, forums, and conventions
• A bachelor of science in engineering or a related technical degree

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Director of Compliance & Validation, 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.

You will be surrounded by exceptional talent who will support your development as both a world‑class engineer and a highly effective leader.