Aseptic Filling & Formulation Process Engineer (Onsite)

Piper Companies; Raleigh (NC); Presencial; USD 90 000 - 130 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health, Vision, Dental benefits

Paid time off (PTO)

Holidays and Sick Leave as required

Resumo da oferta

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to join a leading pharmaceutical manufacturer in RTP, NC. You will provide technical expertise for aseptic filling, formulation, and compounding, supporting capital projects and technology transfers within a GMP-regulated environment.

The role involves collaborating with Manufacturing, Validation, Automation, and Quality teams, spearheading commissioning, qualification, and operational readiness of filling

Qualificações

• 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.

Responsabilidades

• Provide process engineering support for aseptic filling operations in sterile manufacturing.
• 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.

Conhecimentos

Pharmaceutical manufacturing

GMP experience

Aseptic filling

Parenteral manufacturing

Formação académica

Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering

Ferramentas

Vial filling systems

Syringe filling systems

Cartridge filling systems

Isolators

RABS

Cleanroom operations

Descrição da oferta de emprego

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to join a leading pharmaceutical manufacturer in RTP, NC. You will provide technical expertise for aseptic filling, formulation, and compounding, supporting capital projects and technology transfers within a GMP-regulated environment.

The role involves collaborating with Manufacturing, Validation, Automation, and Quality teams, spearheading commissioning, qualification, and operational readiness of filling