Process Engineer: Aseptic Filling & Process Optimization

PCI Pharma Services; Bedford (NH); On-site; USD 85,000 - 110,000; Full time

Job summary

PCI Pharma Services is seeking a Process Engineer to identify and mitigate manufacturing issues across aseptic filling and related operations. You will lead process improvement, commissioning, qualification, and validation of equipment to support production, maintenance, and quality teams.

The role emphasizes data-driven problem solving, SOP development, and collaboration across functions to increase throughput while maintaining strict cGMP standards.

Qualifications

• Bachelor's degree in a STEM field; 3–6 years of pharma cGMP experience preferred.
• Experience with parenteral processing equipment such as filling/packaging is preferred.
• Ability to lead on-the-floor activities like FAT/SAT/IQ/OQ and engineering batches.

Responsibilities

• Support new and existing products, optimize processes, troubleshoot equipment and validate processes.
• Gather data and analyze to minimize waste and variability in manufacturing.
• Lead/assist in commissioning, qualification, and validation of process equipment.
• Write SOPs, test procedures, and engineering batch records; train personnel.
• Ensure utilities and equipment meet specifications and regulatory requirements.
• Maintain safety-first approach and drive continuous improvement.

Skills

Process engineering

Lean Six Sigma

GMP compliance

FAT/SAT/IQ-OQ

Equipment commissioning

Root cause analysis

Cross-functional teamwork

Project management

Technical writing (SOPs)

Education

Bachelor's degree in STEM

Tools

Aseptic Filling Isolator

IQ/OQ validation

Job description

PCI Pharma Services is seeking a Process Engineer to identify and mitigate manufacturing issues across aseptic filling and related operations. You will lead process improvement, commissioning, qualification, and validation of equipment to support production, maintenance, and quality teams.

The role emphasizes data-driven problem solving, SOP development, and collaboration across functions to increase throughput while maintaining strict cGMP standards.