Aseptic Process Engineer - Pharma Manufacturing

pciservices

Bedford (NH)

On-site

USD 85,000 - 110,000

Full time

5 days ago

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Job summary

PCI is seeking a Manufacturing Process Engineer to identify and mitigate manufacturing issues in aseptic filling and other operations. You will lead process improvement projects, assist in commissioning and validation of equipment, and collaborate across functions to maintain quality and safety.

Strong Lean Six Sigma and data analysis skills are essential. The role supports production staff, improves throughput, and may involve overtime.

Qualifications

3–6 years in a Pharma cGMP environment or equivalent experience.
Experience with parenteral processing equipment: formulation, filling, visual inspection, packaging is preferred.
Ability to lead floor activities (FAT, SAT, IQ/OQ) and data-driven root cause analysis.

Responsibilities

Support technical activities for new and existing products and process optimization.
Provide data gathering and analysis to drive projects and reduce variability.
Improve yield and efficiency by reducing human error and equipment failures.
Create and update SOPs, test procedures, and GMP documents; assist training.
Troubleshoot manufacturing equipment; ensure utilities and equipment meet specifications and SOPs/regulations.
Maintain safety-focused process development and manufacturing.
Approve validation/qualification documents as needed and coordinate change controls for equipment.