Director of Validation

Description

• 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
• Develop project scope statements, estimates, and proposals
• 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

Requirements

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

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance