Quality Engineer - Sustaining & NPI Partner

PCI TRGR Penn Pharmaceutical Services Ltd; Philadelphia (Philadelphia County); Hybrid; USD 85,000 - 110,000; Full time

Job summary

PCI Pharma Services in Philadelphia, PA is seeking a Quality Engineer – Sustaining Engineer responsible for ensuring product quality throughout lifecycle as programs transfer from NPI to commercial operations. You will support tech transfer, manage non-conforming material disposition, and drive CAPA to prevent recurrence.

The role collaborates with site leadership, suppliers, and internal teams to standardize processes, develop validation protocols, and improve DFMA, with emphasis on risk

Qualifications

• College or Trade Degree in engineering or related scientific field.
• Minimum three years of experience in an FDA-regulated industry, preferably medical devices.
• Proficiency with ERP and eQMS; ability to create and interpret technical data.
• Lean Six Sigma certification and CQE are highly desirable.

Responsibilities

• Drive and support new customer programs throughout the development lifecycle and deliver the One PCI customer experience.
• Interact with clients to support project milestones and changes.
• Develop and implement product and process workflows for DFA/DFM into sustainable engineering and commercial operations.
• Lead root cause analysis of deviations/complaints and drive CAPA to prevent recurrence.
• Develop Master Batch Records, work instructions, and associated manufacturing documentation.
• Support validation/qualification activities and risk management throughout the product lifecycle.

Skills

Quality Engineering

Root Cause Analysis

Process Validation

Documentation

Education

College or Trade Degree in Engineering

Tools

ERP systems

eQMS systems

MS Office

Job description

PCI Pharma Services in Philadelphia, PA is seeking a Quality Engineer – Sustaining Engineer responsible for ensuring product quality throughout lifecycle as programs transfer from NPI to commercial operations. You will support tech transfer, manage non-conforming material disposition, and drive CAPA to prevent recurrence.

The role collaborates with site leadership, suppliers, and internal teams to standardize processes, develop validation protocols, and improve DFMA, with emphasis on risk