Process Engineer - Aseptic Filling & Formulation Support
Listed on 2026-10-19
-
Engineering
Validation Engineer, Pharma Engineer, Process Engineer, Quality Engineering
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
- Aseptic Filling & Formulation Support will provide technical expertise for aseptic filling, formulation, and compounding processes while supporting critical manufacturing initiatives, facility expansions, technology transfers, and capital projects within a GMP-regulated environment.
The Process Engineer
- Aseptic Filling & Formulation Support role is a long term, open ended contract opportunity and requires you to work onsite in RTP, NC
- Aseptic Filling & Formulation Support:
- Provide process engineering support for aseptic filling operations within sterile manufacturing environments.
- Support startup, commissioning, qualification, and operational readiness activities for filling lines and associated equipment.
- Troubleshoot process and equipment performance issues to improve operational 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 activities, process scale-up efforts, and manufacturing readiness programs.
- Serve as an owner's representative supporting capital projects from design through implementation.
- Interface with engineering firms, equipment vendors, and key internal stakeholders.
- Develop process documentation, engineering deliverables, and technical reports.
- Aseptic Filling & Formulation Support:
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related technical discipline.
- 5+ years of pharmaceutical manufacturing experience within GMP-regulated environments.
- Hands-on experience supporting aseptic filling lines within sterile manufacturing operations.
- Experience with injectable drug product manufacturing and parenteral manufacturing processes.
- Knowledge of sterile formulation, compounding, and aseptic processing technologies.
- Experience with vial, syringe, and/or cartridge filling systems.
- Familiarity with isolators, Restricted Access Barrier Systems (RABS), and cleanroom operations.
- Experience supporting facility expansions, capital projects, commissioning, and qualification activities.
- Understanding of process validation, technology transfer, change management, deviations, and CAPA processes.
- Ability to function independently while managing multiple priorities and project deliverables.
- Aseptic Filling & Formulation Support:
- Salary range:
- Full Comprehensive Benefits:
Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.
's Representative, Cleanroom Operations
This job opens for applications on 10/16/2026. Applications for this job will be accepted for at least 30 days from the posting date.
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