Capital Project Engineer

GenoviceWilmington, DE
Onsite

About The Position

We are seeking two experienced Capital Project Engineers to support the startup of a new pharmaceutical manufacturing facility in Wilmington, Delaware. One engineer will focus primarily on a lyophilizer, while the other will focus on a pharmaceutical filling line.

Requirements

  • Bachelor’s degree in Mechanical, Chemical, Electrical, or a related engineering discipline.
  • Capital project engineering experience within a pharmaceutical, biotechnology, or other regulated manufacturing environment.
  • Hands-on experience bringing pharmaceutical manufacturing equipment online.
  • Working knowledge of GMP requirements and commissioning and qualification practices.
  • Strong vendor-management, troubleshooting, and cross-functional communication skills.
  • Ability to work onsite at the Wilmington, Delaware facility as required.

Nice To Haves

  • Direct experience with either lyophilizers or sterile/aseptic filling equipment is strongly preferred.

Responsibilities

  • Lead capital engineering activities for assigned manufacturing equipment from installation through startup and operational readiness.
  • Support the installation, commissioning, qualification, and startup of a lyophilizer or filling line.
  • Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and Validation teams.
  • Review equipment specifications, drawings, design documents, and vendor documentation.
  • Support FAT, SAT, commissioning, troubleshooting, and turnover activities.
  • Track project schedules, equipment deliverables, technical issues, and action items.
  • Ensure equipment and project activities comply with GMP requirements, engineering standards, and applicable safety regulations.
  • Support the development and execution of equipment turnover and qualification documentation.
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