BW Design Group · 1 day ago
Business Development Director, CSV
Pasadena, CA
Full-time
Onsite
Director/Executive
$150K/yr - $200K/yr
10+ years expBW Design Group is a rapidly growing company with over 1,500 professionals dedicated to shaping the world through their work. As a Director of Compliance & Validation, you will lead a team to support capital projects and implement solutions for clients in the life sciences sector, ensuring the highest quality outcomes through collaboration and expertise.
Industrial Automation
Responsibilities
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
Qualification
Required
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
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
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
Preferred
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
A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis
Company
BW Design Group
BW Design Group is the only independent, fully integrated AEC firm powered by a Manufacturer's Mindset™.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Aderito Dos Santos
Partner
Adolfo Santana
Partner Quality and Regulatory Compliance Consulting Services
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