Sustaining Quality Engineer – Life Sciences Pharma

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

Job summary

PCI Pharma Services in Philadelphia seeks a Quality Engineer - Sustaining Engineer to oversee quality operations as products move from development to manufacturing. You will drive transfer activities, ensure adherence to specifications, and lead CAPA investigations with cross-functional teams.

The role requires an engineering degree and at least three years in an FDA-regulated setting, with strong analytics and documentation skills. Collaboration with customers and suppliers is essential.

Qualifications

• Bachelor's degree in engineering or related scientific field.
• Minimum of three years in an FDA-regulated environment (medical device or combination products preferred).
• Experience with quality systems and data analysis.

Responsibilities

• Lead design/tech transfer activities with NPIs and customers.
• Drive quality operations as product scales into production.
• Dispostion non-conforming product and investigate root causes.
• Support validation/qualification activities and change assessments.
• Collaborate with clients, suppliers and internal teams to ensure quality.

Skills

Quality Engineering

Root Cause Analysis

CAPA

Process Validation

Documentation

Cross-functional Collaboration

Education

Engineering Degree

Tools

MS Office

ERP systems

eQMS

Job description

PCI Pharma Services in Philadelphia seeks a Quality Engineer - Sustaining Engineer to oversee quality operations as products move from development to manufacturing. You will drive transfer activities, ensure adherence to specifications, and lead CAPA investigations with cross-functional teams.

The role requires an engineering degree and at least three years in an FDA-regulated setting, with strong analytics and documentation skills. Collaboration with customers and suppliers is essential.