SME

Exyte GmbH
Raleigh, NC Full Time
POSTED ON 3/4/2024 CLOSED ON 4/2/2024

What are the responsibilities and job description for the SME position at Exyte GmbH?

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.

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
  • Uses specialist 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
  • Other duties as assigned

Show your expertise

  • Bachelor’s degree in Architecture required
  • 15 years of experience in facility planning and design
  • 10 years of consulting experience in biotech/pharmaceuticals
  • 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
  • Experience and comfort working in/with complex corporate environments
  • 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.

#ExyteCareersAreExciting

GET MORE THAN JUST A JOB

    Engineer World Changing Facilities

    Health & Well-being

    Environment of Excellence

    Career Growth

    Commitment to an Incident-Free Workplace (IFW)

    Global Opportunities

CONTACT

Clinton Crellin
518-788-3443
Exyte is an Equal Employment Opportunity employer and is committed to equal opportunity and equal treatment. Therefore, Exyte Group provides equal employment opportunities to all qualified applicants regardless of ancestry, gender, sexual orientation, gender identity, race, color, religion, protected veteran or disability status, or genetic information.
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