Quality Engineer

Job Title

Quality Engineer

New Jersey

Long Term

We are seeking an experienced Quality Engineer to support quality assurance, compliance, validation, and quality systems activities within a pharmaceutical manufacturing environment. This role will focus on ensuring compliance with FDA regulations, cGMP requirements, quality system management, investigations, validation support, and continuous improvement initiatives across manufacturing operations.

• Provide quality oversight for manufacturing operations and ensure compliance with cGMP regulations, FDA requirements, and company quality standards.
• Manage and support quality system activities, including deviations, CAPAs, change controls, non‑conformances, and risk assessments.
• Lead and participate in root cause investigations and implement corrective and preventive actions.
• Review and approve manufacturing records, SOPs, validation protocols, reports, and GMP documentation.
• Support equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and ongoing process verification activities.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory teams to resolve quality and compliance issues.
• Analyze quality metrics and trends to identify opportunities for process improvements and compliance enhancements.
• Support internal audits, supplier quality programs, customer audits, and regulatory inspections.
• Ensure compliance with 21 CFR Part 210/211, ICH guidelines, GDP, and ALCOA+ data integrity principles.
• Promote a culture of quality through training, compliance awareness, and continuous improvement initiatives.

• Bachelor's Degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or a related technical discipline.
• 5+ years of Quality Engineering, Quality Assurance, Validation, or related experience.
• Experience with in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Strong knowledge of quality systems, including deviations, CAPA management, change control, investigations, and risk management.
• Experience supporting equipment qualification, process validation, and manufacturing quality oversight.
• Understanding of cGMP regulations, FDA requirements, data integrity principles, and inspection readiness activities.
• Strong analytical, problem‑solving, technical writing, and communication skills.
• Ability to work effectively in a cross‑functional team environment.
• Experience supporting regulatory, customer, or third‑party audits is preferred.