Aseptic Filling Process Engineer - Onsite

Piper Companies; Indianapolis (IN); Sur place; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Health benefits

Paid time off

Holiday pay

Résumé du poste

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to join a leading pharmaceutical manufacturing organization supporting sterile injectable drug product operations in Indianapolis, IN. The role provides technical expertise for aseptic filling, formulation, and parenteral processes within a GMP-regulated environment.

The position supports capital projects, technology transfers, and manufacturing readiness programs, collaborating with Manufacturing, Validation,

Qualifications

• Bachelors degree in a technical discipline as listed.
• 5+ years of pharmaceutical manufacturing experience in GMP environments.
• Hands-on experience with aseptic filling lines in sterile manufacturing.
• 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, capital projects, commissioning and qualification activities.
• Understanding of process validation, technology transfer, changes, deviations and CAPAs.

Responsabilités

• Provide process engineering support for aseptic filling operations.
• Support startup, commissioning, qualification, and operational readiness activities for filling lines and equipment.
• Troubleshoot process/equipment performance 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.
• Collaborate with Manufacturing, Validation, Automation and QA teams for project execution.
• Participate in technology transfer, process scale-up, and manufacturing readiness programs.
• Serve as owner’s representative on capital projects from design to implementation.
• Interface with engineering firms, equipment vendors and internal stakeholders.
• Develop process documentation, engineering deliverables and technical reports.

Connaissances

Aseptic filling support

Sterile manufacturing

Process validation

Technology transfer

CAPA & deviations

Parenteral manufacturing

vial/syringe/cartridge filling

Isolators/RABS/cleanroom

Formation

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

Description du poste

Piper Companies is seeking a Process Engineer - Aseptic Filling & Formulation Support to join a leading pharmaceutical manufacturing organization supporting sterile injectable drug product operations in Indianapolis, IN. The role provides technical expertise for aseptic filling, formulation, and parenteral processes within a GMP-regulated environment.

The position supports capital projects, technology transfers, and manufacturing readiness programs, collaborating with Manufacturing, Validation,