Project Engineer - III (Senior)

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

Requirements

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

Preferred Experience and Skills

• Experience with isolator filling

About the role

• Contractor role supporting Drug Product operations
• Assignment planned for one year, with a possible one-year extension
• Both remote and hybrid options available
• Role can be remote, but West Point is the preferred location; local candidates may be expected to come onsite 1-2 days per week
• Travel may be required up to 25%, mainly to North Carolina and Indiana

The ideal candidate should have 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.

Responsibilities

• Author, review, and maintain GMP technical documentation with clarity, accuracy, and compliance to applicable regulatory and quality requirements, including:
  • 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:
  • 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
• Support the commercial manufacture of Drug Product (Form / Fill) at the client’s External Partner network sites