Senior Project Engineer

This is a 12-month contract role with the potential for extensions. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship. Both remote and hybrid options available; the role can be remote, but West Point, PA is the preferred location. Local candidates may be expected to come onsite 1-2 days per week.

About the Role

This position supports the commercial manufacture of Drug Product (Form/Fill) at the client's External Partner network sites. The role involves process-related technical change controls across multiple sites, including work with SOPs, procedures, systems, emails, meetings, and stakeholder coordination. Travel may be required up to 25%, primarily to North Carolina and Indiana.

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
• Provide floor support as needed for Person-In-Plant activities at External Partner sites

Requirements

• Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, 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 Qualifications

• Experience with isolator filling
• Strong technical operations experience in sterile liquids, injectables, vials, and syringes (not solid dosage)
• Key skills: change control ownership/execution, organization, planning, statistical understanding, cross-functional communication, teamwork, and ability to work independently

Pay

$70.00 - $80.00/hr (W2 contract, no PTO, no benefits). ACA-compliant supplemental package available for enrollment.