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Senior Process Architect

4 weeks ago

Raleigh, North Carolina, United States Exyte Full time
Job Description

Exyte is seeking a highly skilled Senior Process Architect to join our team. As a key member of our facility planning and design team, you will be responsible for developing facility concepts that meet operational and business goals for manufacturing assets in the Life Science Industry.

Key Responsibilities:

  • Develop facility concepts around operational and business goals for manufacturing assets in the Life Science Industry
  • Develop feasibility and concept studies that meet globally recognized regulatory guidelines for GMP
  • Develop feasibility and concept studies that meet Client guidelines as defined in Tender documents
  • Conduct reviews of facility risks and facilitate implementation of facility planning approaches to mitigate those risks
  • Deliver on-the-job knowledge sharing/training/mentoring within technical discipline
  • Follows technology trends and maintains knowledge within technical discipline
  • Supports development of new methods/tools/ for feasibility and CD execution and improve existing solutions supporting compliant facility planning
  • Stays current in global regulations impacting facility attributes for the manufacture of biologics and pharmaceutical drug substance and drug product
  • Integrates with other disciplines, both internal and Client resources, to optimize facility solutions
  • Supports development of optimized facility standards for global use across the Company
  • Ensures use of best practice within recognized Industry facility models
  • Participates actively in relevant cross-organizational/cross site standardized solutions specifically for feasibility and conceptual design
  • Participates in Industry forums to expand the growth of the Company and our Body of Knowledge
  • Attends special courses/practical training in field of expertise

Requirements:

  • Recognized expert within process architecture discipline, specific to biologics and pharmaceutical manufacturing
  • Versed in global regulatory aspects of GMP related to facility design
  • Adept at finding innovative methods and solutions for Customer/project/business requirements
  • Fluent in the use of Visio and CAD platforms and other visual tools to present ideas and solutions
  • Ability to communicate design solutions and use of methods, tools and technology in solutions, to a global audience
  • Excellent verbal and written communication skills
  • Bachelor's degree in architecture required
  • Registered Architect in the state of NC
  • 15+ years of experience in facility planning and design
  • 10+ years of consulting experience in biotech/pharmaceuticals
  • Experience with business development, such as developing specific proposals and interviewing for RFPs
  • Experience and comfort working in/with complex corporate environments