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Validation Manager (Design Group)

Design Group is a leading Engineering, systems integration, and IT consulting firm, capable of providing complete operating solutions for consumer products, life sciences, and other industrial sectors. Design Group provides engineering, project management, regulatory compliance, and other technology services to the world?s leading companies. Our organization is staffed by over 1,400 engineering and technical specialists, operating from over 40 global offices in the US and India,? Design Group provides professional engineering, architectural and construction management services through our wholly owned and professionally licensed subsidiary, Design Group Facility Solutions, Inc.


We are focused on providing our professionals with opportunities for leadership and career advancement within a thriving work environment and a unique ?people-centric? culture. We offer a robust, centralized learning and development program to improve the career experience for every professional.


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 more than 11,600 team members united by a common belief: to use the power of business to build a better world. For more information, go to www.barrywehmiller.com ?and visit our CEO Bob Chapman?s blog at www.trulyhumanleadership.com.


The Validation Manager will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment.


Education



  • BS Degree in Engineering or related technical degree.


Experience



  • Minimum of 7 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 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.

  • Project Management experience in managing scope, cost, schedule, quality and risk is required.

  • Experience in team building, mentorship and multi-discipline collaboration

  • Displayed leadership in a consulting and service environment


Requirements/Responsibilities



  • Validation Manager will 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.

  • The Validation Manager will be responsible for developing project scope statements, estimates and proposals.?

  • This role will assist in the development of policies, programs and project master planning.

  • This position requires 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.?

  • 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 and

  • This position requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.


Travel Requirements



  • 20% Travel required.


Design Group provides a unique professional experience



  • Investment in each professional through mentorship and career development

  • Strong history of employment stability and robust national expansion plan

  • Fostering culture of partnership and recognition


Directs the engineering activities of the assigned function or department within the organization
 

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