Capital Project Engineer

Job Description

Job Description

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.