Project Engineer - III (Senior)

Client is seeking a highly motivated individual for a technical operations contractor position.

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.)
• Prior experience and competency with change control
• 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%(NC/Indiana)

Preferred Experience and Skills:

Experience with isolator filling.

Key Skills:

• Client External Manufacturing Technical Operations Contractor role supporting Drug Product operations.
• The assignment is planned for one year, with a possible one-year extension.
• Both remote and hybrid options available. The role can be remote, but West Point is the preferred location; local candidates may be expected to come onsite a few days(1-2days) per week.
• The ideal candidate should have around 6+ years of experience and strong technical operations experience in sterile liquids, injectables, vials, and syringes-not solid dosage.
• Key skills include change control ownership/execution, organization, planning, statistical understanding, cross-functional communication, teamwork, and ability to work independently.
• The role will involve process-related technical change controls across multiple sites, including work with SOPs, procedures, systems, emails, meetings, and stakeholder coordination.
• Travel will be up to 25%, mainly to North Carolina and Indiana.

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.

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 and execution
  • 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