Aseptic Filling Process Engineer — Innovate & Optimize

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 90,000 - 130,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd in Bedford, NH is seeking a Manufacturing Process Engineer to optimize aseptic and filling operations, lead qualification of equipment, and drive continuous improvement across manufacturing lines. The role emphasizes Lean Six Sigma methods, SOPs, and cross-functional collaboration to ensure quality, safety, and throughput.

The candidate will support validation activities, lead CAPA efforts, and participate in FAT/SAT, IQ/OQ, and engineering batches.

Qualifications

• Minimum of 3–6 years in a pharma cGMP environment.
• Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging is preferred.
• Ability to manage on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches.
• Experience with data-driven root cause analysis and continuous improvement prioritization.
• Proficiency in engineering documentation and report writing.
• High level of problem solving and analytical reasoning.
• Strong written and verbal communication skills.

Responsibilities

• Support process optimization, troubleshooting, and validation for existing products.
• Lead commissioning, qualification, and validation of process equipment.
• Write SOPs, test procedures, batch records, and GMP documents.
• Lead CAPA investigations and manufacturing investigations as needed.
• Coordinate FAT/SAT activities and change controls; collaborate cross-functionally.
• Ensure safety, quality, and regulatory compliance in manufacturing processes.

Skills

Data-driven root cause analysis

Lean Six Sigma

Regulatory compliance

Project management

SOP writing

Cross-functional collaboration

Job description

PCI TRGR Penn Pharmaceutical Services Ltd in Bedford, NH is seeking a Manufacturing Process Engineer to optimize aseptic and filling operations, lead qualification of equipment, and drive continuous improvement across manufacturing lines. The role emphasizes Lean Six Sigma methods, SOPs, and cross-functional collaboration to ensure quality, safety, and throughput.

The candidate will support validation activities, lead CAPA efforts, and participate in FAT/SAT, IQ/OQ, and engineering batches.