Director, Compliance and Validation

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Director, Compliance and Validation Apply locations East Brunswick, NJ time type Full time posted on Posted Yesterday job requisition  R018991

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients.

Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

• Job Description

  Director of Compliance & Validation,
  Life Sciences

  Who You’ll Work With

  You will join our Indianapolis office which is 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.

  When you join Design Group as a Director of Compliance & Validation , you are joining a team that will challenge you and position you for growth. 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.

  What You’ll Do

  You'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

  • 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

  What You’ll Bring

  • 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
  • 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
  • A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred)
  • An understanding of…