Job Details

  • Title: Process Engineer
  • Code: RCI-19061-1
  • Location: Sanford North Carolina (NC) 27330
  • Posted Date: 06/26/2020
  • Duration: 12 Months
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  Job Description

POSITION SUMMARY:

  • This job description applies to the capital project to create a new Gene Therapy facility.
  • This role will report to the process engineering lead and is expected to be 30-36 months in duration.
  • The successful candidate will provide engineering input to support the design effort and subsequent phases for each of the following elements, throughout the project delivery lifecycle of a new Drug Substance high capacity manufacturing facility:
  • This key role will directly provide process design subject matter expertise in cell culture, transfection, purification, fill finish and support services design for a new Gene Therapy manufacturing operation.
  • The role will have direct input into key decisions within the design for a new Gene Therapy facility from the perspective of process equipment design, and how this relates to how the facility and process equipment will be installed, automated, commissioned, operated and supported.
  • This role will extend through preliminary & detailed design, construction, commissioning and verification/qualification, and start-up.
  • The Engineer II will be responsible for designing the process equipment, while interfacing with an operations team that provide requirements into how the equipment should function.
  • In addition, the Engineer II will interface with automation and verification colleagues to ensure streamlined startup and handover of the facility to operations team members, as well as seamless integration into site engineering and automation systems.
  • The Engineer II will work closely with Global Engineering within company to ensure that the design fully leverages past experiences and best practices.
POSITION RESPONSIBILITIES:
  • Provide technical engineering input to scope definition, specification and procurement for process equipment.
  • Review and approval of A/E firm process engineering design deliverables
  • Review and approval of equipment package bid analyses.
  • Provide engineering input into overall facility layout and design.
  • Support input to the development of detailed capital project execution schedule
  • Provide engineering input into cost estimate preparation for the project.
  • Ensure process design quality and design change.
  • Participate in equipment start up as a part of multi-disciplined team
  • Ensure design documents are maintained through project life-cycle for turn over.
  • Identify project risks and opportunities and propose mitigation plans.
  • Lead up to 3 junior engineers
ORGANIZATIONAL RELATIONSHIPS:
  • Startup and Verification team
  • Process Engineering team
EDUCATION & EXPERIENCE:
  • EDUCATION REQUIREMENTS: Min qualification – Degree in Chemical/Mechanical Engineering, or related field with 5 years of experience in this field.
BASIC-MANDATORY QUALIFICATIONS:
  • Experience of A/E Design Firm project execution
  • Minimum (5 years) biopharmaceutical engineering project experience.
  • Minimum (2 years) biopharmaceutical equipment operation/start up
  • Previous experience in design of project >$10 MM required
  • Knowledge of upstream, downstream and fill finish processes within either mammalian cell culture or vaccines manufacturing facilities. Previous Gene Therapy experience is preferred
  • Direct operational experience within either mammalian cell culture or vaccines manufacturing facilities, gene therapy facilities is preferred.
  • Knowledge and experience of project execution for fully automated facility design
  • Knowledge of Delta V.
  • Experience of facility design in a 3D Model / BIM environment utilizing integrated project delivery
  • Experience with 3D model and client design reviews
  • Experience of Equipment vendor package management and design coordination
  • Knowledge and experience of Bio-pharmaceutical commissioning & qualification, with knowledge of ASTM E2500 a particular advantage.
  • Good understanding of risk management methodologies, with a proven ability to apply in Bio-pharmaceutical operations.
  • Strong knowledge of problem solving, root cause analysis, operational excellence techniques. Six Sigma experience an advantage.
  • Ability to read/understand P&IDs and electrical single line drawings.
PREFERRED QUALIFICATIONS:
  • Startup and commissioning safety