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BW Design Group · 19 hours ago

Director, Compliance and Validation

Indianapolis, IN

Full-time

Onsite

Director/Executive

10+ years exp

BW Design Group is a rapidly growing firm in the life sciences sector, seeking a Director of Compliance & Validation. In this role, you will lead a team of validation professionals, provide subject matter expertise, and support capital projects to help clients improve performance and achieve their goals.

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

Ensure project objectives are met

Make an impact day-to-day with your skills and expertise, strengthening relationships with our clients and teams

Qualification

Validation/Quality ServiceBusiness DevelopmentProject ManagementCQV Project LeadershipEPCMV UnderstandingCGMP KnowledgeProcess AutomationLife Sciences PassionEngineering DegreeTechnical WritingMentorship ExperienceCollaboration Skills

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

Experience developing business and client relationships

The ability to read engineering documents and experience in proposal development

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