Aseptic Fill Process Engineer

PCI Pharma Services; Bedford (AL); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services in Bedford, AL is seeking a Process Engineer to identify and mitigate manufacturing issues across aseptic filling, capping/lyophilization, and related operations. You will lead process improvement, qualification, and validation activities to support production, maintenance, and quality teams.

The role requires hands-on problem solving, data-driven root cause analysis, and collaboration with cross-functional partners to reduce waste, increase throughput, and ensure GMP

Qualifications

• Pharma cGMP environment experience required.
• Experience with aseptic filling and related equipment.
• Ability to manage FAT/SAT/IQ/OQ and engineering batches.
• Strong data-driven problem solving and root cause analysis.
• Excellent documentation and SOP writing skills.

Responsibilities

• Support technical activities related to new and existing products, process optimization, and validation.
• Provide data gathering and analysis to support projects and reduce waste.
• Maximize manufacturing success by reducing human error and improving yield.
• Write SOPs, test procedures, and GMP documents; assist training.
• Troubleshoot equipment and ensure utilities meet specs.
• Maintain safety-first approach in process development.
• Approve validation protocols as needed.
• Commissioning of equipment including change controls, FAT/SAT.
• Research trends in aseptic filling and coordinate outside services.
• Lead investigations and CAPA as needed.
• Write and execute engineering protocols.
• Overtime/weekend work may be required.
• Adhere to PCI, cGMP, GCP policies.
• Performs other duties as assigned.

Skills

GMP compliance

FAT/SAT/IQ/OQ

Data analysis

Cross-functional collaboration

Project management

Job description

PCI Pharma Services in Bedford, AL is seeking a Process Engineer to identify and mitigate manufacturing issues across aseptic filling, capping/lyophilization, and related operations. You will lead process improvement, qualification, and validation activities to support production, maintenance, and quality teams.

The role requires hands-on problem solving, data-driven root cause analysis, and collaboration with cross-functional partners to reduce waste, increase throughput, and ensure GMP