Project Engineer - III (Senior)

Client is seeking a highly motivated individual for a technical operations contractor position. This role will primarily support the commercial manufacture of Drug Product (Form / Fill) at the client's External Partner network sites inclusive of the responsibilities below.

Education Minimum Requirement:

• Bachelor's degree in Chemical / Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.

Required Experience and Skills:

• Minimum of 6 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering
• Min 3 years of experience supporting sterile / aseptic drug product filling (vials, syringes, etc.)
• Statistics experience
• Strong communication and teamwork skills
• Demonstrated ability to independently manage projects/work to schedule/deadlines
• Travel may be required but not to exceed 25%

Preferred Experience and Skills:

• Experience with isolator filling

Important Note:

REMOTE ROLE WITH 25% TRAVEL EXPECTED at the client's External Partner network sites.

Responsibilities include:

• Author, review, and maintain GMP technical documentation with clarity, accuracy, and compliance to applicable regulatory and quality requirements. Documents include:
  
  
  
  • Change control ownership
  • Protocols and technical reports
  • Continued Process Verification (CPV) plans, data sets, trend analyses, and periodic reports
  
  
  
  
• Perform statistical data extraction and analysis to support proactive process analysis. Typical activities:
  
  
  
  • Pull and validate production, quality, and process control data from relevant GMP sources or approved data trending systems
  • Apply statistical process control (SPC), capability analysis, and other appropriate methods
  • Create visualizations and summary metrics to support assessment outputs
  
  
  
  
• Contribute to continuous improvement initiatives, including data-driven process optimization and documentation standardization
• Floor support as needed for Person-In-Plant activities at External Partner