Process Engineer - Aseptic Filling & Formulation Support

Piper Companies; Raleigh (NC); On-site; USD 90,000 - 117,000; Full time

Job summary

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to support a leading pharmaceutical manufacturing organization in Raleigh, NC. The role focuses on aseptic manufacturing operations, capital expansion, technology transfers, and manufacturing readiness initiatives.

Ideal candidates will have hands-on experience with sterile injectable products, GMP-regulated environments, and experience with isolators and RABS.

Qualifications

• 5+ years of experience in process/manufacturing engineering within pharmaceutical or life sciences environments.
• Hands-on experience supporting aseptic filling, sterile formulation, injectable drug products, or parenteral manufacturing operations.
• Knowledge of GMP requirements and experience with commissioning, qualification, validation, CAPAs, and change controls.
• Involvement with facility expansions, capital projects, process validation, and technology transfer initiatives.

Responsibilities

• Provide technical support for aseptic filling, sterile formulation, and parenteral manufacturing processes to ensure efficiency and compliance.
• Support commissioning, qualification, startup, and manufacturing readiness activities for new lines, equipment, and facility expansions.
• Collaborate with Manufacturing, Quality, Validation, Automation, and Engineering teams to resolve process challenges and drive improvements.
• Lead or support investigations, deviations, CAPAs, and change controls in aseptic operations.
• Coordinate with vendors and internal stakeholders to execute technology transfer, scale-up, and capital projects.

Skills

Aseptic filling

Sterile formulation

Parenteral manufacturing

GMP compliance

Technology transfer

Manufacturing readiness

Capital projects

CQV

Commissioning

Qualification

Tools

Isolators

RABS

Filling systems

Job description

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to support a leading pharmaceutical manufacturing organization in Raleigh, NC. The Process Engineer - Aseptic Filling & Formulation Support role requires working onsite and will focus on aseptic manufacturing operations, capital expansion projects, technology transfers, and manufacturing readiness initiatives. The Process Engineer - Aseptic Filling & Formulation Support role is ideal for an experienced engineer with expertise in sterile manufacturing, injectable drug products, and GMP-regulated environments.

Responsibilities of the Process Engineer - Aseptic Filling & Formulation Support include:

• Provide technical support for aseptic filling, sterile formulation, and parenteral manufacturing processes to ensure operational efficiency and compliance.
• Support commissioning, qualification, startup, and manufacturing readiness activities for new production lines, equipment, and facility expansions.
• Partner with Manufacturing, Quality, Validation, Automation, and Engineering teams to resolve process challenges and drive continuous improvement efforts.
• Lead or support investigations, deviations, CAPAs, and change controls associated with aseptic manufacturing operations.
• Coordinate with vendors, engineering firms, and internal stakeholders to execute technology transfer, scale-up, and capital project activities.

Requirements of the Process Engineer - Aseptic Filling & Formulation Support include:

• 5+ years of experience in process engineering, manufacturing engineering, or project engineering within pharmaceutical, biotech, or life sciences environments.
• Hands‑on experience supporting aseptic filling, sterile formulation, injectable drug products, or parenteral manufacturing operations.
• Experience with vial, syringe, or cartridge filling systems, as well as isolators, RABS, or other aseptic processing technologies.
• Knowledge of GMP requirements and experience supporting commissioning, qualification, validation, deviations, CAPAs, and change controls.
• Previous involvement with facility expansions, capital projects, process validation, manufacturing readiness, or technology transfer initiatives.

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

• $65 - $85/hr
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.
• Long-term contract opportunity with potential for extension.

This job opens for applications on 10/14/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Process Engineer, Aseptic Filling, Sterile Formulation, Injectable Drug Products, Parenteral Manufacturing, Process Validation, Technology Transfer, Manufacturing Readiness, Capital Projects, GMP, CQV, Commissioning, Qualification, Isolators, RABS, Vial Filling, Syringe Filling, Pharmaceutical Manufacturing, Raleigh, NC

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