Process Engineer - Aseptic Filling & Formulation Support - 176745 - 176746

Piper Companies; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health, Vision, and Dental benefits

Paid time off (PTO)

Holidays & Sick Leave as required by

Job summary

Piper Companies seeks a Process Engineer for Aseptic Filling & Formulation Support to join a leading pharmaceutical manufacturer supporting sterile injectable drug products. The role is onsite in RTP, NC and focuses on aseptic filling, formulation, and compounding processes.

The successful candidate will support startup, commissioning, qualification, technology transfers, and capital projects within a GMP environment, collaborating with Manufacturing, Validation, Automation, and Quality teams.

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or related field.
• 5+ years of pharmaceutical manufacturing experience in GMP environments.
• Hands-on experience supporting aseptic filling lines in sterile manufacturing.

Responsibilities

• Provide process engineering support for aseptic filling operations.
• Support startup, commissioning, qualification and readiness activities for filling lines and equipment.
• Troubleshoot process/equipment to improve efficiency and reliability.
• Review and optimize aseptic workflows and production processes.
• Support investigations, deviations, CAPAs, and change controls.

Skills

Aseptic filling

Sterile manufacturing

GMP

Technology transfer

Capital projects

Deviations & CAPA

Change control

Process validation

Vial/Syringe/Cartridge filling

Isolators/RABS

Education

Bachelor's degree in Chemical/Mechanical/Pharma Eng

Tools

Isolators

RABS

Cleanroom operations

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 10/26/2026. Applications for this job will be accepted for at least 30 days from the posting date.