Quality Engineer, Sustaining: Global Impact in Biopharma

PCI Pharma Services

Philadelphia (Philadelphia County)

On-site

USD 85,000 - 120,000

Full time

14 days+

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Job summary

PCI Pharma Services in Philadelphia is seeking a Quality Engineer – Sustaining Engineer to lead quality lifecycle activities as products transfer from NPI to commercial operations. You will drive design/tech transfer, ensure products meet control plans and specifications, and partner with site leadership to reduce variation in manufacturing and packaging processes.

You will perform root-cause analysis, CAPA, and data-driven improvements, support validation and qualification activities, and

Qualifications

Bachelor's degree or trade equivalent; minimum 3 years in an FDA-regulated industry (medical device/biologics preferred).
Proficiency with MS Office; experience with ERP/eQMS tools and data presentation.
Strong root-cause analysis and problem-solving skills; ability to drive CAPA and continuous improvement.

Responsibilities

Lead quality lifecycle activities for sustaining engineering and product transfers from NPI to commercial operations.
Disposition non-conforming product; drive CAPA and root-cause investigations.
Support validation/qualification activities and provide documentation (MRA, Control Plans, inspection plans).
Collaborate with clients, suppliers, and internal teams to ensure compliant, high-quality manufacturing and packaging.