Capital Project Engineer

Capital Project Engineer

Capital Project Engineer – Pharmaceutical Manufacturing

Location:

Wilmington, Delaware

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.

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.