Director of Validation

Barry-Wehmiller • Raleigh, NC

13d

About The Position

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 BW Design Group as a Director of 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 collaborate with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

Requirements

• A minimum of ten years of experience/leadership 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 in proposal development
• Diverse experience leading 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)
• 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
• A passion for a career in the life science industry
• Strong project management software and word processing skills, and solid technical writing skills
• The ability to read engineering documents
• Experience in mentorship, multi-discipline collaboration, and in a consulting and service environment
• A bachelor of science in engineering, biology, chemistry or a related technical degree

Nice To Haves

• Diverse experience leading 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)
• A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred)

Responsibilities

• Lead local business development efforts and expand engagements with existing clients
• Develop project scope statements, estimates, and proposals
• Provide subject matter expertise in the validation of a variety of utility, facility, and process equipment
• Make an impact day-to-day with your skills and expertise, initiating and strengthening relationships with our clients and team
• Lead a team of technical professionals and interface with clients

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees