Project Manager, Validation

Barry-Wehmiller•Raleigh, NC

6d•Hybrid

About The Position

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping 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, they combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of their clients. Rooted in their distinct culture of Truly Human Leadership, they cultivate leaders who will define tomorrow and partner with 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. When you join Design Group as a Project Manager, 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 their Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to clients with consistency and accuracy.

Requirements

Minimum of 5 years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
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.
Requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.
Project Management experience in managing scope, cost, schedule, quality, and risk is required.
BS Degree in Engineering or related technical degree.

Nice To Haves

Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
Experience with financial systems, project, and client administration.
Diverse experience in 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 is desirable.
Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
Experience in mentorship and multi-discipline collaboration.
Displayed leadership in a consulting and service environment.

Responsibilities

Work individually and in teams to support capital projects and implement solutions for clients.
Help clients make critical changes to improve their performance and realize their most important goals.
Interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
Help lead business development efforts in the region as it relates to engaging with new clients in the life sciences sector, and expanding engagements with existing clients.
Develop project scope statements, estimates and proposals.
Work on multiple projects simultaneously.
Make an impact day-to-day with skills and expertise, strengthening relationships with clients and team.