SME - Process Architecture

Discover your exciting role

The SME - Process Architecture is responsible for providing knowledge across all platforms and will support biologics, pharmaceuticals, and drug product manufacturing feasibility/concept development. Also responsible for layout options, flows, segregation, and facility optimization that will be the key drivers in final deliverable products. Must be proficient in communications of operational analysis and design basis in order to align Customer needs and expectations with deliverables.

Non-Solicitation:  We are not currently accepting third-party agency candidates for this position. Any agency candidate submitted to any employee of Exyte may be contacted by Exyte without obligation to the third-party agency.

Explore your tasks and responsibilities

• Develops facility concepts around operational and business goals for manufacturing assets in the Life Science Industry
• Develops feasibility and concept studies that meet globally recognized regulatory guidelines for GMP
• Develops feasibility and concept studies that meet Client guidelines as defined in Tender documents
• Conducts reviews of facility risks and facilitate implementation of facility planning approaches to mitigate those risks 
• Must have knowledge and experience to solve complex tasks around segregation strategy, functional adjacencies, GMP flows, and equipment integration into facility layouts
• Delivers 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

The information contained in this job description is intended to describe the essential job functions required of those assigned to this job. It is not intended to be an exhaustive list of all responsibilities, duties, knowledge, skills, and abilities needed to perform the job. Please note that management retains the right to assign or reassign duties and responsibilities to this job at any time. The ability to competently perform all the essential duties of the position, with or without reasonable accommodation, demonstrated commitment to effective customer service delivery, integrity, and the ability to work productively as a member of a team or work group are basic requirements of all positions at Exyte Group.

Show your expertise

Skills & Knowledge

• 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

Experience & Education

• 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

Preferred

• Registered Architect in multiple states (in addition to NC)
• Experience with multi-product facility design, single use based manufacturing platforms, advanced therapeutic product facilities
• Experience in the execution (design, build, start-up) of capex projects for drug substance and drug product manufacturing