Quality Engineer

Katalyst CRO; Illinois City (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a detail-oriented Quality Engineer with hands-on experience in the pharmaceutical industry to support quality engineering activities across manufacturing and laboratory operations. The ideal candidate will manage deviations, CAPA, change control, and validation, review batch records and SOPs, and ensure GMP, cGMP, and GLP compliance.

You will collaborate with QA, QC, Manufacturing, Validation and Engineering teams to drive continuous improvement and maintain compliant

Qualifications

• 4+ years of Quality Engineering experience in pharma or life sciences.
• Strong knowledge of GMP, cGMP, GLP and regulatory requirements.
• Experience with deviation management, CAPA, change control and validation.
• Ability to review SOPs, batch records and technical documents.
• Experience supporting FDA audits or regulatory inspections.
• Knowledge of risk management and quality systems.

Responsibilities

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure GMP, cGMP, and GLP standards.
• Assist in method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Monitor quality metrics, trends, and recurring issues to drive continuous improvement.
• Assist in internal audits, compliance reviews, and inspection readiness.
• Maintain accurate and compliant quality documentation and records.

Skills

Deviation management

CAPA

Change control

Validation

GMP compliance

Quality documentation

Regulatory inspections

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Bachelor's degree in Pharmacy

Job description

Summary

We are seeking a detail-oriented Quality Engineer with experience in the pharmaceutical industry to support quality engineering activities across manufacturing and laboratory operations. The ideal candidate will have hands-on experience with deviations, CAPA, change control, validation, and GMP compliance.

Responsibilities

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Assist in method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Monitor quality metrics, trends, and recurring issues to drive continuous improvement.
• Assist in internal audits, compliance reviews, and inspection readiness.
• Maintain accurate and compliant quality documentation and records.

Education

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field.
• 4+ years of experience in Quality Engineering within the pharmaceutical or life sciences industry.
• Strong knowledge of GMP, cGMP, GLP, and regulatory compliance requirements.
• Experience with deviation management, CAPA, change control, and validation processes.
• Ability to review and interpret technical documents, SOPs, and batch records.
• Experience supporting FDA audits or regulatory inspections.
• Knowledge of risk management and quality systems.
• Familiarity with validation lifecycle (IQ, OQ, PQ).