Director, Compliance and Validation

Overview

Lead validation teams, manage compliance projects, develop client solutions in life sciences.

Key Responsibilities

• validation expertise
• project delivery
• team leadership
• business development
• engineering guidance
• scope development

Tasks

-Provide subject matter expertise in the validation of a variety of utility, facility, and process equipment -Ensure project objectives are met -Lead a team of validation professionals and interface with clients -Lead regional business development efforts and expand engagements with existing clients -Ensures components, materials, and tools are used to capacity. -Make an impact day-to-day with your skills and expertise, strengthening relationships with our clients and teams -Leads and directs the work of other employees. Implements effective engineering methods and provides technical guidance and acts as a resource for engineers. -Advises management in developing processes, policies, and procedures. -Develop project scope statements, estimates, and proposals

Requirements

• 10+ years
• bsc engineering
• project management
• cgmp
• fmea
• gamp

What You Bring

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

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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.

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