Validation Manager

Barry-Wehmiller • Raleigh, NC

70d

About The Position

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 five 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)
• The ability to read engineering documents
• 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 bachelor of science in engineering, biology, chemistry or a related technical degree

Responsibilities

• Lead local business development efforts and expand engagements with existing clients
• Lead a team of technical professionals and interface with 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees