Quality Engineer - Sustaining & Process Excellence

PCI TRGR Penn Pharmaceutical Services Ltd; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services is actively seeking a Quality Engineer – Sustaining Engineer to manage the product quality lifecycle from NPI transfer to commercial operations at our Philadelphia site.

Based in Philadelphia, PA, you will drive design and process transfer, support validation, CAPA, and risk management, and partner with operations, suppliers, and customers to ensure compliant, high‑quality products reaching patients.

Qualifications

• Requires a degree in engineering or science and experience in FDA-regulated environments.
• Proficient in root-cause analysis and CAPA processes.
• Experience with validation, qualification, and change assessment activities.
• Ability to develop and interpret technical documentation and quality systems.
• Excellent collaboration with internal teams, suppliers and customers.

Responsibilities

• Drive and support new customer programs across development to commercial operations.
• Interact with clients to support milestones, scope changes and business opportunities.
• Develop and implement workflows for DFA/DFM to support sustainable operations.
• Transfer test methods and perform validations as needed.
• Develop Master Batch Records, work instructions, and related documentation.
• Lead root cause analysis of deviations and drive CAPA.

Skills

Quality engineering

Root cause analysis

CAPA

Documentation

Data analysis

FDA regulated

Education

Bachelor's degree in engineering or science

Tools

MS Office

ERP

eQMS

Validation

Technical writing

Job description

PCI Pharma Services is actively seeking a Quality Engineer – Sustaining Engineer to manage the product quality lifecycle from NPI transfer to commercial operations at our Philadelphia site.

Based in Philadelphia, PA, you will drive design and process transfer, support validation, CAPA, and risk management, and partner with operations, suppliers, and customers to ensure compliant, high‑quality products reaching patients.