Engineering Client Development Lead, Validation and Regulatory Compliance

Engineering Client Development Lead, Validation and Regulatory Compliance

Join BW Design Group as an Engineering Client Development Lead, Validation and Regulatory Compliance. This position focuses on leading a Regulatory Compliance Validation team for pharmaceutical, biotech and medical device manufacturing projects in the Southern California area.

You will join one of our 45 offices in the US, be part of a committed team 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.

In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

• Lead with an uplifting entrepreneurial spirit
• Inspire excellence in all aspects of performance and project execution
• Display enthusiasm and excitement for client projects that lift project teams to high levels of job satisfaction
• Consistently seek new value‑add opportunities for clients and 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
• Communicate and interact directly with clients in a collaborative and professional manner
• 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.
• Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills.
• Prepare or review budgets based on experience and scope of project.
• Assist 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

• 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,…