Aseptic Filling Process Engineer – Sterile Manufacturing

Piper Companies; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental benefits

PTO & paid holidays

On-site work in RTP, NC

Job summary

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to join a leading pharmaceutical manufacturing organization supporting sterile injectable drug product operations. The Process Engineer will provide technical expertise for aseptic filling, formulation, and compounding processes within a GMP-regulated environment.

The role is a long-term, open-ended contract and requires onsite work in RTP, NC.

Qualifications

• 5+ years of pharmaceutical manufacturing experience within GMP-regulated environments.
• Hands-on experience with aseptic filling lines in sterile operations.
• Experience with injectable drug product manufacturing and parenteral processes.
• Knowledge of sterile formulation, compounding, and aseptic processing technologies.
• Experience with vial, syringe, and/or cartridge filling systems.
• Familiarity with isolators, RABS, and cleanroom operations.
• Experience supporting facility expansions and capital projects, commissioning and qualification activities.
• Understanding of process validation, technology transfer, change management, deviations, and CAPA processes.

Responsibilities

• Provide process engineering support for aseptic filling operations within sterile manufacturing environments.
• Support startup, commissioning, qualification, and operational readiness for filling lines and equipment.
• Troubleshoot process and equipment performance issues to improve efficiency and reliability.
• Review, evaluate, and optimize aseptic manufacturing workflows and production processes.
• Support investigations, deviations, CAPAs, and change controls related to aseptic processing operations.
• Collaborate with Manufacturing, Validation, Automation, and Quality teams to ensure successful project execution.
• Participate in technology transfer, process scale-up, and manufacturing readiness programs.
• Serve as an owner's representative supporting capital projects from design through implementation.
• Interface with engineering firms, equipment vendors, and internal stakeholders.
• Develop process documentation, engineering deliverables, and technical reports.

Skills

Aseptic filling

Parenteral manufacturing

GMP compliance

Technology transfer

CAPA & change control

Qualification/validation

Education

Bachelor's degree in Chemical Engineering or related

Job description

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to join a leading pharmaceutical manufacturing organization supporting sterile injectable drug product operations. The Process Engineer will provide technical expertise for aseptic filling, formulation, and compounding processes within a GMP-regulated environment.

The role is a long-term, open-ended contract and requires onsite work in RTP, NC.