Director, Compliance and Validation

About the role

You will join our East Brunswick, New Jersey office, be part of a committed organization of over 1,500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

Responsibilities

• Work individually and in teams to support capital projects and implement solutions for our clients.
• Help our clients make critical changes to improve their performance and realize their most important goals.
• Leverage past professional experiences, along with BW Design Group’s engineering offering to expand our presence in the Life Science market sector in and around the New Jersey market.
• Lead a Regulatory Compliance Validation team for pharmaceutical, biotech and medical device manufacturing projects for our clients.
• Actively be involved in the execution and leading of all phases of projects.
• Lead with an uplifting entrepreneurial spirit.
• Inspire excellence in all aspects of performance and project execution.
• Display enthusiasm and excitement for client projects that lifts project teams to high levels of job satisfaction.
• Consistently seek new value-add opportunities for clients and BW Design Group.
• Meet with clients to define the program requirements based on an understanding of the client's production process flow and space environmental needs derived from meetings with the client and the review of any documentation provided by the client.
• Assess the requirements of a project, break a project into tasks, and work with teams to determine scope of work, budget and staffing.
• Create integrated solutions and communicate key concepts to the client.
• Develop the base plan and coordinate technical requirements with engineering disciplines.
• Understand and develop design intent based on client objectives and provide excellent client service.
• Research material options to deliver an optimal solution for the client when required by project scope.
• Assign and review work of project team. Check progress of work and alert project leads to change of scope or additional services.
• Carefully coordinate all aspects of project document completion within company and externally with clients and other design professionals.
• Prepare or review budgets based on experience and scope of project.
• Aid in the education and development of the team and act as resource for questions.
• Innovate and improve design and service delivery method and processes.
• Build and sustain long term client and internal relationships.
• Participate actively in relevant industry organization events and conferences.
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.

Requirements

• A passion for a career in the Life Science industry.
• 15+ years of Life Science operational & engineering experience in the pharmaceutical, biotech or medical device sectors - Client side & Consulting experience highly preferred.
• 10+ years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
• Diverse experience in 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 is desirable.
• Demonstrated client development experience and excellent presentation skills.
• Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
• Experience building, managing, and leading teams.
• Experience with creating proposals and business development.
• Experience with financial systems, project, and client administration.
• Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
• Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
• Project Management experience in managing scope, cost, schedule, quality and risk is required.
• Excellent time management skills and ability to multi-task on simultaneous projects.
• Displayed leadership in a consulting and service environment.
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

Qualifications

• BS Degree in Engineering or related technical degree.