Director, Process Specialist, GS&T

IPS-Integrated Project Services•Cary, NC

About The Position

IPS is seeking a Director, Process Specialist to join its Global Strategy & Technology (GS&T) team. The role designs and implements manufacturing processes, equipment, and plants, from pilot scale through fully operational facilities. It also supports corporate process and manufacturing technical services and programs that advance the corporate strategic plan. The position works with pharmaceutical clients on process design and related project activities, including concept development, project documentation, technical consulting, and coordination with internal and external project stakeholders. Travel depends on project location. This is a safety-sensitive role that includes field work and attendance at client sites in construction, process, packaging, manufacturing, research, or other non-administrative areas.

Requirements

  • More than 15 years of process design experience in the pharmaceutical industry, working in one or more of oral solid dosage (OSD), aseptic, or biologics.
  • Bachelor’s degree from an accredited university or college in engineering or a relevant science.
  • Strong proficiency with office software, including MS Word, Excel, PowerPoint, MS Project, and Visio.
  • GMP design experience.
  • General knowledge of system design and applicable process engineering codes.
  • Proven experience interacting and communicating directly with clients and leading conceptual design efforts.
  • Demonstrated ability to manage projects, solve problems, communicate effectively with key personnel, manage time, and work on multiple projects at once.
  • Ability to travel based on project location.
  • Ability to perform field work and attend client sites in non-administrative areas.

Nice To Haves

  • Active participation in industry organizations and related initiatives, such as speaking engagements or presenting at industry events and conferences.

Responsibilities

  • Assess project requirements, break projects into tasks, and work with a Project Manager to determine scope of work.
  • Write process and manufacturing scopes of work based on preliminary reviews and client meetings.
  • Support concept development and project design.
  • Prepare engineering studies and schematic designs for new systems, and analyze the operation of existing systems.
  • Document project process requirements, including process descriptions, technology evaluations, process flow diagrams, capacity analyses, and equipment lists.
  • Consult on specialized projects such as technology transfer and process improvement.
  • Maintain satisfactory relationships with clients, consultants, and other vested interests.
  • Promote the use of, and participate in developing, company design and production standards.
  • Coordinate completion of project documents within the company and externally with clients and other design professionals.
  • Occasionally support business development activities, including proposals and presentations.
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