Director of Validation

Overview

Lead validation projects, business development, and client engagements in life sciences.

Key Responsibilities

• team lead
• client interface
• subject expertise
• scope development
• business development
• client relations

Tasks

-Lead a team of technical 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 local business development efforts and expand engagements with existing clients -Make an impact day-to-day with your skills and expertise, initiating and strengthening relationships with our clients and team

Requirements

• project management
• cgmp
• epcmv
• fmea
• gamp
• b.sc.

What You Bring

-Project management experience involving scope, budget, schedule, quality, risk, and client management -Experience in proposal development -An understanding of good documentation practices, cGMP, and FDA validation methods and systems -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 -A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred) -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 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 -The ability to read engineering documents -A bachelor of science in engineering, biology, chemistry or a related technical degree -Strong project management software and word processing skills, and solid technical writing skills -Experience in mentorship, multi-discipline collaboration, and in a consulting and service environment

People Also Searched For

About Bw Design Group

-Provides cutting-edge software tools and professional services for network design and optimization. -Recognized for versatility across industries, from telecommunication to utility networks. -Dedicated to continuous innovation and enhancement of customer value.

Sector Specialisms