Director, Compliance and Validation

Description

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

Requirements

• 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
• 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
• 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)
• The ability to read engineering documents and experience in proposal development
• Experience developing business and client relationships
• 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
• A bachelor of science in engineering or a related technical degree
• An understanding of good documentation practices, cGMP, and FDA validation methods and systems
• Work on multiple projects simultaneously
• 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 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

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance