Process Engineer - Aseptic Filling

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 - 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

Responsibilities of the Process Engineer - 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.

Requirements of the Process Engineer - 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.

Compensation for the Process Engineer - Aseptic Filling & Formulation Support:

• Salary range:
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.

Keywords:

Aseptic Filling, Process Engineer, Pharmaceutical Manufacturing, Sterile Manufacturing, Injectable Drug Products, Parenteral Manufacturing, GMP, Sterile Formulation, Compounding Operations, Filling Lines, Vial Filling, Syringe Filling, Cartridge Filling, Isolators, RABS, Commissioning, Qualification, CQV, Technology Transfer, Process Validation, Manufacturing Readiness, Capital Projects, Facility Expansion, Process Engineering, Deviation Management, CAPA, Change Control, Validation, Drug Product Manufacturing, Sterile Processing, Owner's Representative, Cleanroom Operations

This job opens for applications on 11/6/2026. Applications for this job will be accepted for at least 30 days from the posting date.