Capital Project Engineer

Genovice

Capital Project EngineerCapital Project Engineer – Pharmaceutical Manufacturing Location: Wilmington, DelawareWe 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.Key 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.Qualifications: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.Direct experience with either lyophilizers or sterile/aseptic filling equipment is strongly preferred.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.

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