SME - Process Architecture

2 months ago

Raleigh, United States Exyte Full time
Your vision is ambitious. Just like ours.

Our people are our success. As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community of challenge seekers who are ambitious and passionate about innovation. Together, we will build on our company's long history and keep on leading the way to a better world.

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

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