Pharma Process Engineer – Aseptic Filling & Process Improvement

PCI Pharma Services; Tennessee; On-site; USD 75,000 - 110,000; Full time

Job summary

PCI Pharma Services is seeking a Process Engineer to identify and mitigate manufacturing issues across aseptic filling, capping/lyo operations, and related processes. The role focuses on improving processes, equipment validation, and ensuring quality, safety, and throughput in a fast-paced pharmaceutical environment.

The engineer will lead commissioning activities, write GMP documents, and collaborate with cross-functional teams to drive continuous improvement, CAPA, and lean initiatives.

Qualifications

• Minimum of 3–6 years in a Pharma cGMP environment.
• Experience with parenteral processing equipment (formulation, filling, visual inspection, packaging) preferred.
• Ability to lead on-the-floor activities (FAT, SAT, IQ/OQ, engineering batches).
• Data-driven root cause analysis and prioritization of continuous improvement.

Responsibilities

• Support technical activities for new and existing products, process optimization, equipment troubleshooting, and process validation.
• Provide data gathering and analysis to support projects and reduce waste/variability.
• Maximize manufacturing success by reducing human error, equipment failures, and improving yield/efficiency.
• Write SOPs, test procedures, batch records, and related GMP documents; assist training.
• Troubleshoot equipment and ensure utilities meet specifications and comply with SOPs/regulations.
• Maintain a safety-first approach in process development and manufacturing.
• Approve validation protocols and related documents as needed.
• Coordinate commissioning of equipment including change controls, FAT/SAT, and external design/manufacturing services.
• Research new trends in aseptic filling and evaluate/testing of new equipment.
• Collaborate on development of equipment performance requirements.
• Lead investigations and CAPA initiatives as needed.
• Write and execute engineering protocols.
• Overtime/weekend work may be required.
• Adhere to PCI, cGMP, and GCP policies.

Skills

Aseptic processing knowledge

Process optimization

Troubleshooting

CAPA

Data analysis

Project management

Education

Pharmaceutical engineering degree

Tools

Lean Six Sigma

FAT/SAT

Job description

PCI Pharma Services is seeking a Process Engineer to identify and mitigate manufacturing issues across aseptic filling, capping/lyo operations, and related processes. The role focuses on improving processes, equipment validation, and ensuring quality, safety, and throughput in a fast-paced pharmaceutical environment.

The engineer will lead commissioning activities, write GMP documents, and collaborate with cross-functional teams to drive continuous improvement, CAPA, and lean initiatives.